ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment (AVOID-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01474200
Recruitment Status : Terminated (Closed due to patient recruitment challenges. No interim analyses were completed; study closure was not related to any concerns about safety or futility.)
First Posted : November 18, 2011
Results First Posted : October 12, 2015
Last Update Posted : May 10, 2017
Sponsor:
Collaborators:
Gambro UF Solutions, Inc.
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Heart Failure
Cardiac Failure
Acute Decompensated Heart Failure (ADHF)
Interventions Device: Isolated veno-venous ultrafiltration (AQ)
Drug: IV Loop Diuretics (LD)
Enrollment 224
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines. Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Period Title: Overall Study
Started 110 114
Completed 81 84
Not Completed 29 30
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD) Total
Hide Arm/Group Description Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines. Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol. Total of all reporting groups
Overall Number of Baseline Participants 110 111 221
Hide Baseline Analysis Population Description
3 patients in the IV Loop Diuretics (LD) arm were randomized, but withdrawn from the study prior to beginning study treatment. These patients are excluded from the number of baseline participants (analysis population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 111 participants 221 participants
67.03  (12.61) 66.87  (13.45) 66.95  (13.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 111 participants 221 participants
Female
34
  30.9%
30
  27.0%
64
  29.0%
Male
76
  69.1%
81
  73.0%
157
  71.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 111 participants 221 participants
American Indian or Alaska Native
2
   1.8%
3
   2.7%
5
   2.3%
Asian
1
   0.9%
3
   2.7%
4
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
31
  28.2%
30
  27.0%
61
  27.6%
White
75
  68.2%
71
  64.0%
146
  66.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.9%
4
   3.6%
5
   2.3%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 110 participants 111 participants 221 participants
172.45  (11.04) 174.12  (10.52) 173.29  (10.79)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 110 participants 111 participants 221 participants
110.06  (32.26) 110.92  (35.09) 110.49  (33.64)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 110 participants 111 participants 221 participants
36.89  (10.13) 36.32  (10.10) 36.61  (10.10)
1.Primary Outcome
Title Time to First Heart Failure (HF) Event
Hide Description

Time to first HF event within 90 days after discharge from index HF hospitalization. HF events are defined as

  • HF rehospitalization or
  • unscheduled outpatient or emergency room treatment with IV loop diuretics or
  • unscheduled outpatient Aquapheresis treatment
Time Frame 90 days after discharge from index HF hospitalization.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results reported are for the 25th percentile.
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 110 111
Median (95% Confidence Interval)
Unit of Measure: Days
62 [1] 
(42 to NA)
34
(20 to 62)
[1]
We are unable to estimate the upper limit of the confidence interval due to lack of events.
2.Secondary Outcome
Title EFFICACY: Total Fluid Removed During the Index Hospitalization
Hide Description AQ-Fluid removed by AQ plus urine voided versus urine voided when treated with IV diuretics
Time Frame Index Hospitalization, an average of 8 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 108 109
Mean (Standard Deviation)
Unit of Measure: mL
18700  (23033) 14043  (15299)
3.Secondary Outcome
Title EFFICACY: Net Fluid Removed During the Index Hospitalization
Hide Description AQ-Fluid removed by AQ plus urine voided minus fluid intake versus urine voided minus fluid intake with the IV diuretics.
Time Frame Index Hospitalization, an average of 8 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 108 109
Mean (Standard Deviation)
Unit of Measure: mL
12921  (20564) 8907  (13329)
4.Secondary Outcome
Title EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment
Hide Description Weight at 72 hours after treatment initiation minus weight at treatment initiation. Negative mean values indicate weight loss.
Time Frame 72 hours after treatment initiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 85 82
Mean (Standard Deviation)
Unit of Measure: lbs
-10.69  (7.20) -10.30  (9.22)
5.Secondary Outcome
Title EFFICACY: Total Weight Loss During the Index Hospitalization
Hide Description Weight at hospital discharge minus weight at hospital admission. Negative mean values indicate weight loss.
Time Frame Index Hospitalization, an average of 8 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 104 108
Mean (Standard Deviation)
Unit of Measure: lbs
-17.12  (12.59) -16.21  (14.23)
6.Secondary Outcome
Title EFFICACY: Time to Freedom From Congestion
Hide Description Time from hospital admission to time patient is free of congestion in the hospital. Freedom from congestion is defined as jugular venous distention of < or equal to 8 cm, with no orthopnea and with trace peripheral edema or no edema. Measurement taken every 24 hours after treatment initiation.
Time Frame Index Hospitalization, an average of 8 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 40 46
Mean (Standard Deviation)
Unit of Measure: Days
5.28  (4.11) 3.86  (3.23)
7.Secondary Outcome
Title EFFICACY: Freedom From Congestion
Hide Description Defined as jugular venous distention of < or equal to 8 cm, with no orthopnea, and with trace peripheral edema or no edema at hospital discharge
Time Frame Index Hospitalization, an average of 8 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 110 111
Measure Type: Number
Unit of Measure: Participants
40 46
8.Secondary Outcome
Title EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time
Hide Description Change in BNP levels over time at 72 hours, discharge, and 90 days after discharge.
Time Frame Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed changes over time. Baseline: n=108 for AQ arm, n=109 for LD arm. 72 hours from baseline: n=81 for AQ arm, n=77 for LD arm. Discharge: n=83 for AQ arm, n=89 for LD arm. 90 days follow up: n=65 for AQ arm, n=76 for LD arm.
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 108 109
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline 814.0  (827.66) 904.1  (843.44)
72 hours from baseline -169.8  (450.57) -120.5  (469.04)
Discharge -250.2  (527.12) -219.1  (539.26)
90 days after discharge -159.9  (678.20) -201.3  (618.31)
9.Secondary Outcome
Title CLINICAL: Length of Stay (LOS) During the Index Hospitalization
Hide Description Number of days patient is in hospital for HF treatment.
Time Frame Index hospitalization admission to index hospitalization discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 105 108
Mean (Standard Deviation)
Unit of Measure: Days
8.49  (5.73) 7.19  (5.37)
10.Secondary Outcome
Title CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge
Hide Description Days rehospitalized for HF symptoms requiring hospital, emergency room or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs.
Time Frame Within 30 days and 90 days after hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 110 111
Measure Type: Number
Unit of Measure: Days
30 days after discharge 68 172
90 days after discharge 338 460
11.Secondary Outcome
Title CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge
Hide Description Number of visits for HF symptoms requiring ED or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs
Time Frame Within 30 days and 90 days after hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 110 111
Measure Type: Number
Unit of Measure: Visits
30 days after discharge 4 5
90 days after discharge 7 8
12.Secondary Outcome
Title CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge
Hide Description Number of different times patient was admitted to hospital for HF symptoms within 90 days of index hospitalization discharge.
Time Frame Within 30 days and 90 days after hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 110 111
Measure Type: Number
Unit of Measure: Rehospitalizations
30 days after discharge 11 24
90 days after discharge 36 52
13.Secondary Outcome
Title CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge
Hide Description CV symptoms that required hospitalization for treatment within 90 days of index hospitalization discharge.
Time Frame Within 30 days and 90 days after hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 110 111
Measure Type: Number
Unit of Measure: Rehospitalizations
30 days after discharge 17 33
90 days after discharge 46 66
14.Secondary Outcome
Title CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge
Hide Description The total number of days spent in the hospital due to CV related events at 30 days and 90 days from hospital discharge.
Time Frame Within 30 days and 90 days after hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 110 111
Measure Type: Number
Unit of Measure: Days
30 days after discharge 88 207
90 days after discharge 377 554
15.Secondary Outcome
Title CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days
Hide Description Any cause that required hospitalization for treatment within 90 days of index hospitalization discharge.
Time Frame Within 30 days and 90 days after hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 110 111
Measure Type: Number
Unit of Measure: Rehospitalizations/100 Pt-Days at Risk
30 days after discharge 0.899 1.278
90 days after discharge 1.109 1.237
16.Secondary Outcome
Title CLINICAL: Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge.
Hide Description Death due to any cause.
Time Frame Time from randomization to 90 days post-hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 110 111
Measure Type: Number
Unit of Measure: Percentage of Participants
15.45 12.61
17.Secondary Outcome
Title CLINICAL: Days Alive and Out of Hospital at 30 and 90 Days After Discharge
Hide Description Number of days patients were alive and out of the hospital.
Time Frame Within 30 and 90 days after hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 105 108
Mean (Standard Deviation)
Unit of Measure: Days
30 days after discharge 27.29  (5.78) 26.46  (6.34)
90 days after discharge 62  (24.57) 61.38  (24.95)
18.Secondary Outcome
Title CLINICAL: Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge
Hide Description Questionnaire assessed patients quality of life prior to index treatment versus timeframes following hospital discharge. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.
Time Frame Within 90 days after hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed changes over time. Baseline: n=107 for AQ arm, n=110 for LD arm. 30 day follow up: n=85 for AQ arm, n=91 for LD arm. 90 day follow up: n=72 for AQ arm, n=77 for LD arm.
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 107 110
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 25.39  (19.37) 28.64  (22.59)
30 days after discharge 52.06  (28.58) 49.36  (28.82)
90 days after discharge 59.72  (24.90) 58.50  (26.72)
19.Secondary Outcome
Title CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge
Hide Description KCCQ Questionnaire analysis based on patient's self-assessment of how they feel at various intervals compared to how they felt prior to index treatment. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.
Time Frame Within 90 days after hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed changes over time. Baseline: n=107 for AQ arm, n=110 for LD arm. 30 day follow up: n=85 for AQ arm, n=92 for LD arm. 90 day follow up: n=72 for AQ arm, n=77 for LD arm.
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 107 110
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 28.26  (18.65) 31.83  (18.63)
30 days after discharge 54.78  (24.15) 53.08  (26.01)
90 days after discharge 57.21  (25.39) 60.56  (26.34)
20.Secondary Outcome
Title SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization
Hide Description Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula
Time Frame Within 90 days of randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 105 108
Mean (Standard Deviation)
Unit of Measure: mg/dL
Discharge 0.12  (0.42) 0.12  (0.50)
30 days after discharge 0.37  (3.41) 0.17  (0.63)
60 days after discharge 1.34  (11.40) -0.01  (0.44)
90 days after discharge -0.30  (0.42) -0.24  (0.30)
21.Secondary Outcome
Title SAFETY: Changes in Renal Function (Blood Urea Nitrogen) After Treatment up to 90 Days After Randomization
Hide Description Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula
Time Frame Within 90 days of randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed changes over time. Baseline: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 105 108
Mean (Standard Deviation)
Unit of Measure: mg/dL
Discharge 8.38  (13.94) 7.62  (14.34)
30 days after discharge 1.72  (14.44) 6.56  (22.80)
60 days after discharge 1.85  (16.62) 3.16  (17.78)
90 days after discharge 2.50  (6.36) -3.78  (4.19)
22.Secondary Outcome
Title SAFETY: Changes in Renal Function (Blood Urea Nitrogen/Serum Creatinine) After Treatment up to 90 Days After Randomization
Hide Description Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula
Time Frame Within 90 days of randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 105 108
Mean (Standard Deviation)
Unit of Measure: mg/dL
Discharge 3.77  (7.80) 3.03  (6.52)
30 days after discharge 0.28  (6.88) 1.65  (8.85)
60 days after discharge 0.07  (7.07) 1.97  (7.42)
90 days after discharge 5.66  (1.40) 1.72  (5.56)
23.Secondary Outcome
Title SAFETY: Changes in Renal Function (Estimated Glomerular Filtration Rate) After Treatment up to 90 Days After Randomization
Hide Description Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula
Time Frame Within 90 days of randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description:
Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
Overall Number of Participants Analyzed 105 108
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m2
Discharge -2.31  (14.50) -2.68  (13.45)
30 days after discharge -0.56  (14.24) -3.33  (14.97)
60 days after discharge -2.49  (16.81) 2.15  (13.79)
90 days after discharge 5.70  (8.06) 7.41  (11.87)
Time Frame Baseline through 90 days after discharge.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Hide Arm/Group Description Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines. Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
All-Cause Mortality
Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Affected / at Risk (%) Affected / at Risk (%)
Total   73/110 (66.36%)   67/111 (60.36%) 
Cardiac disorders     
Cardiac Failure  1  5/110 (4.55%)  8/111 (7.21%) 
Cardiac Failure Acute  1  13/110 (11.82%)  19/111 (17.12%) 
Cardiac Failure Congestive  1  11/110 (10.00%)  20/111 (18.02%) 
Acute Coronary Syndrom  1  1/110 (0.91%)  0/111 (0.00%) 
Acute Myocardial Infarction  1  1/110 (0.91%)  0/111 (0.00%) 
Arrhythmia  1  1/110 (0.91%)  0/111 (0.00%) 
Atrial Fibrillation  1  3/110 (2.73%)  2/111 (1.80%) 
Atrioventricular Block Second Degree  1  1/110 (0.91%)  0/111 (0.00%) 
Cardiac Arrest  1  3/110 (2.73%)  2/111 (1.80%) 
Cardiac Failure Chronic  1  2/110 (1.82%)  3/111 (2.70%) 
Cardio-Respiratory Arrest  1  2/110 (1.82%)  1/111 (0.90%) 
Cardiogenic Shock  1  1/110 (0.91%)  0/111 (0.00%) 
Cardiomyopathy  1  1/110 (0.91%)  1/111 (0.90%) 
Cardiorenal Syndrome  1  0/110 (0.00%)  1/111 (0.90%) 
Cardiovascular Insufficiency  1  1/110 (0.91%)  0/111 (0.00%) 
Congestive Cardiomyopathy  1  1/110 (0.91%)  0/111 (0.00%) 
Cor Pulmonale  1  0/110 (0.00%)  2/111 (1.80%) 
Ischaemic Cardiomyopathy  1  0/110 (0.00%)  1/111 (0.90%) 
Myocardial Infarction  1  1/110 (0.91%)  0/111 (0.00%) 
Palpitations  1  1/110 (0.91%)  0/111 (0.00%) 
Right Ventricular Failure  1  0/110 (0.00%)  1/111 (0.90%) 
Supra Ventricular Tachycardia  1  0/110 (0.00%)  1/111 (0.90%) 
Ventricular Tachycardia  1  2/110 (1.82%)  0/111 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain Lower  1  0/110 (0.00%)  1/111 (0.90%) 
Abdominal Pain Upper  1  0/110 (0.00%)  1/111 (0.90%) 
Abdominal Wall Haematoma  1  1/110 (0.91%)  0/111 (0.00%) 
Gastric Antral Vascular Ectasia  1  1/110 (0.91%)  0/111 (0.00%) 
Gastrointestinal Haemorrhage  1  2/110 (1.82%)  1/111 (0.90%) 
Lower Gastrointestinal Haemorrhage  1  1/110 (0.91%)  0/111 (0.00%) 
Pancreatitis  1  1/110 (0.91%)  0/111 (0.00%) 
Upper Gastrointestinal Haemorrhage  1  0/110 (0.00%)  1/111 (0.90%) 
General disorders     
Chest Pain  1  4/110 (3.64%)  1/111 (0.90%) 
Cardiac Death  1  0/110 (0.00%)  1/111 (0.90%) 
Chest Discomfort  1  1/110 (0.91%)  0/111 (0.00%) 
Death  1  0/110 (0.00%)  3/111 (2.70%) 
Device Lead Issue  1  0/110 (0.00%)  1/111 (0.90%) 
Malaise  1  1/110 (0.91%)  0/111 (0.00%) 
Medical Device Complication  1  0/110 (0.00%)  1/111 (0.90%) 
Non-Cardiac Chest Pain  1  1/110 (0.91%)  1/111 (0.90%) 
Pain  1  0/110 (0.00%)  1/111 (0.90%) 
Pyrexia  1  1/110 (0.91%)  0/111 (0.00%) 
Hepatobiliary disorders     
Gallbladder Perforation  1  0/110 (0.00%)  1/111 (0.90%) 
Immune system disorders     
Sarcoidosis  1  1/110 (0.91%)  0/111 (0.00%) 
Infections and infestations     
Pneumonia  1  5/110 (4.55%)  0/111 (0.00%) 
Cellulitis  1  2/110 (1.82%)  2/111 (1.80%) 
Filariasis  1  1/110 (0.91%)  0/111 (0.00%) 
Infection  1  2/110 (1.82%)  0/111 (0.00%) 
Sepsis  1  1/110 (0.91%)  1/111 (0.90%) 
Septic Shock  1  0/110 (0.00%)  1/111 (0.90%) 
Staphylococcal Infection  1  1/110 (0.91%)  0/111 (0.00%) 
Upper Respiratory Tract Infection  1  2/110 (1.82%)  0/111 (0.00%) 
Urinary Tract Infection  1  0/110 (0.00%)  1/111 (0.90%) 
Wound Infection  1  1/110 (0.91%)  0/111 (0.00%) 
Injury, poisoning and procedural complications     
Hip Fracture  1  1/110 (0.91%)  0/111 (0.00%) 
Procedural Haemorrhage  1  1/110 (0.91%)  0/111 (0.00%) 
Renal Haematoma  1  1/110 (0.91%)  0/111 (0.00%) 
Spinal Compression Fracture  1  1/110 (0.91%)  0/111 (0.00%) 
Vascular Graft Thrombosis  1  1/110 (0.91%)  0/111 (0.00%) 
Investigations     
Blood Creatinine Increase  1  4/110 (3.64%)  0/111 (0.00%) 
Anticoagulation Drug Level Below Therapeautic  1  1/110 (0.91%)  0/111 (0.00%) 
Cardiac Output Decreased  1  1/110 (0.91%)  0/111 (0.00%) 
Haematocrit Decreased  1  1/110 (0.91%)  0/111 (0.00%) 
International Normalised Ratio Increased  1  1/110 (0.91%)  0/111 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/110 (0.91%)  0/111 (0.00%) 
Fluid Overload  1  1/110 (0.91%)  3/111 (2.70%) 
Hyperkalaemia  1  1/110 (0.91%)  0/111 (0.00%) 
Hypoglycaemia  1  1/110 (0.91%)  0/111 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  0/110 (0.00%)  1/111 (0.90%) 
Cervical Spinal Stenosis  1  1/110 (0.91%)  0/111 (0.00%) 
Nervous system disorders     
Cerebrovascular Accident  1  1/110 (0.91%)  1/111 (0.90%) 
Cerebrovascular Disorder  1  0/110 (0.00%)  1/111 (0.90%) 
Encephalopathy  1  0/110 (0.00%)  1/111 (0.90%) 
Headache  1  0/110 (0.00%)  1/111 (0.90%) 
Neurological Symptom  1  2/110 (1.82%)  1/111 (0.90%) 
Neuropathy Peripheral  1  1/110 (0.91%)  0/111 (0.00%) 
Presyncope  1  0/110 (0.00%)  1/111 (0.90%) 
Syncope  1  2/110 (1.82%)  1/111 (0.90%) 
Transient Ischaemic Attack  1  0/110 (0.00%)  1/111 (0.90%) 
Psychiatric disorders     
Confusional State  1  1/110 (0.91%)  0/111 (0.00%) 
Depression  1  1/110 (0.91%)  0/111 (0.00%) 
Renal and urinary disorders     
Renal Failure Acute  1  4/110 (3.64%)  3/111 (2.70%) 
Haematuria  1  1/110 (0.91%)  0/111 (0.00%) 
Renal Failure  1  1/110 (0.91%)  0/111 (0.00%) 
Renal Failure Chronic  1  2/110 (1.82%)  0/111 (0.00%) 
Renal Impairment  1  1/110 (0.91%)  0/111 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure  1  1/110 (0.91%)  1/111 (0.90%) 
Chronic Respiratory Failure  1  0/110 (0.00%)  1/111 (0.90%) 
Dyspnoea  1  3/110 (2.73%)  0/111 (0.00%) 
Hypoxia  1  0/110 (0.00%)  1/111 (0.90%) 
Pickwickian Syndrome  1  0/110 (0.00%)  1/111 (0.90%) 
Pleural Effusion  1  1/110 (0.91%)  1/111 (0.90%) 
Pulmonary Hypertension  1  0/110 (0.00%)  1/111 (0.90%) 
Respiratory Distress  1  0/110 (0.00%)  1/111 (0.90%) 
Surgical and medical procedures     
Cardiac Ablation  1  0/110 (0.00%)  1/111 (0.90%) 
Cardioversion  1  1/110 (0.91%)  2/111 (1.80%) 
Implantable Defibrillator Insertion  1  3/110 (2.73%)  0/111 (0.00%) 
Ventricular Assist Device Insertion  1  0/110 (0.00%)  1/111 (0.90%) 
Vascular disorders     
Hypotension  1  3/110 (2.73%)  5/111 (4.50%) 
Deep Vein Thrombosis  1  1/110 (0.91%)  1/111 (0.90%) 
Hypertensive Crisis  1  0/110 (0.00%)  1/111 (0.90%) 
Orthostatic Hypotension  1  0/110 (0.00%)  1/111 (0.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration IV Loop Diuretics (LD)
Affected / at Risk (%) Affected / at Risk (%)
Total   25/110 (22.73%)   18/111 (16.22%) 
Infections and infestations     
Urinary Tract Infection  1  3/110 (2.73%)  7/111 (6.31%) 
Investigations     
Blood Creatinine Increase  1  7/110 (6.36%)  4/111 (3.60%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  8/110 (7.27%)  4/111 (3.60%) 
Renal and urinary disorders     
Renal Failure Acute  1  5/110 (4.55%)  7/111 (6.31%) 
Vascular disorders     
Hypotension  1  12/110 (10.91%)  7/111 (6.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Due to patient recruitment challenges, the study was terminated early. At that time, no interim analyses of the data had been completed; therefore the decision to close the study was not related to any underlying concerns about safety or futility.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Drew Jones, MD, Senior Medical Director
Organization: Baxter Healthcare Corporation
Phone: 224-270-2659
Publications:
Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01474200     History of Changes
Other Study ID Numbers: Gambro 1494
First Submitted: November 11, 2011
First Posted: November 18, 2011
Results First Submitted: July 23, 2015
Results First Posted: October 12, 2015
Last Update Posted: May 10, 2017