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

This study has been terminated.
(Closed due to patient recruitment challenges. No interim analyses were completed; study closure was not related to any concerns about safety or futility.)
Sponsor:
Collaborator:
Gambro UF Solutions, Inc.
Information provided by (Responsible Party):
Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:
NCT01474200
First received: November 11, 2011
Last updated: September 11, 2015
Last verified: September 2015
Results First Received: July 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 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.
IV Loop Diuretics (LD) 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.

Participant Flow:   Overall Study
    Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration     IV Loop Diuretics (LD)  
STARTED     110     114  
COMPLETED     81     84  
NOT COMPLETED     29     30  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration 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.
IV Loop Diuretics (LD) 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 Total of all reporting groups

Baseline Measures
    Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration     IV Loop Diuretics (LD)     Total  
Number of Participants  
[units: participants]
  110     111     221  
Age  
[units: Years]
Mean (Standard Deviation)
  67.03  (12.61)     66.87  (13.45)     66.95  (13.01)  
Gender  
[units: Participants]
     
Female     34     30     64  
Male     76     81     157  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     2     3     5  
Asian     1     3     4  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     31     30     61  
White     75     71     146  
More than one race     0     0     0  
Unknown or Not Reported     1     4     5  
Height  
[units: Centimeters]
Mean (Standard Deviation)
  172.45  (11.04)     174.12  (10.52)     173.29  (10.79)  
Weight  
[units: Kilograms]
Mean (Standard Deviation)
  110.06  (32.26)     110.92  (35.09)     110.49  (33.64)  
Body Mass Index (BMI)  
[units: Kg/m2]
Mean (Standard Deviation)
  36.89  (10.13)     36.32  (10.10)     36.61  (10.10)  



  Outcome Measures
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1.  Primary:   Time to First Heart Failure (HF) Event   [ Time Frame: 90 days after discharge from index HF hospitalization. ]

2.  Secondary:   EFFICACY: Total Fluid Removed During the Index Hospitalization   [ Time Frame: Index Hospitalization, an average of 8 days ]

3.  Secondary:   EFFICACY: Net Fluid Removed During the Index Hospitalization   [ Time Frame: Index Hospitalization, an average of 8 days ]

4.  Secondary:   EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment   [ Time Frame: 72 hours after treatment initiation ]

5.  Secondary:   EFFICACY: Total Weight Loss During the Index Hospitalization   [ Time Frame: Index Hospitalization, an average of 8 days ]

6.  Secondary:   EFFICACY: Time to Freedom From Congestion   [ Time Frame: Index Hospitalization, an average of 8 days ]

7.  Secondary:   EFFICACY: Freedom From Congestion   [ Time Frame: Index Hospitalization, an average of 8 days ]

8.  Secondary:   EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time   [ Time Frame: Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge ]

9.  Secondary:   CLINICAL: Length of Stay (LOS) During the Index Hospitalization   [ Time Frame: Index hospitalization admission to index hospitalization discharge ]

10.  Secondary:   CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge   [ Time Frame: Within 30 days and 90 days after hospital discharge ]

11.  Secondary:   CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge   [ Time Frame: Within 30 days and 90 days after hospital discharge ]

12.  Secondary:   CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge   [ Time Frame: Within 30 days and 90 days after hospital discharge ]

13.  Secondary:   CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge   [ Time Frame: Within 30 days and 90 days after hospital discharge ]

14.  Secondary:   CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge   [ Time Frame: Within 30 days and 90 days after hospital discharge ]

15.  Secondary:   CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days   [ Time Frame: Within 30 days and 90 days after hospital discharge ]

16.  Secondary:   CLINICAL: Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge.   [ Time Frame: Time from randomization to 90 days post-hospital discharge ]

17.  Secondary:   CLINICAL: Days Alive and Out of Hospital at 30 and 90 Days After Discharge   [ Time Frame: Within 30 and 90 days after hospital discharge ]

18.  Secondary:   CLINICAL: Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge   [ Time Frame: Within 90 days after hospital discharge ]

19.  Secondary:   CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge   [ Time Frame: Within 90 days after hospital discharge ]

20.  Secondary:   SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization   [ Time Frame: Within 90 days of randomization ]

21.  Secondary:   SAFETY: Changes in Renal Function (Blood Urea Nitrogen) After Treatment up to 90 Days After Randomization   [ Time Frame: Within 90 days of randomization ]

22.  Secondary:   SAFETY: Changes in Renal Function (Blood Urea Nitrogen/Serum Creatinine) After Treatment up to 90 Days After Randomization   [ Time Frame: Within 90 days of randomization ]

23.  Secondary:   SAFETY: Changes in Renal Function (Estimated Glomerular Filtration Rate) After Treatment up to 90 Days After Randomization   [ Time Frame: Within 90 days of randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Drew Jones, MD, Senior Medical Director
Organization: Baxter Healthcare Corporation
phone: 224-270-2659
e-mail: drew_jones@baxter.com


Publications:


Responsible Party: Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier: NCT01474200     History of Changes
Other Study ID Numbers: Gambro 1494
Study First Received: November 11, 2011
Results First Received: July 23, 2015
Last Updated: September 11, 2015
Health Authority: United States: Institutional Review Board