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Aquaresis Utility for Hyponatremic Acute Heart Failure Study (AQUA-AHF)

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ClinicalTrials.gov Identifier: NCT02183792
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Tien Ng, University of Southern California

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heart Failure
Interventions Drug: Tolvaptan
Drug: Furosemide
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tolvaptan Furosemide
Hide Arm/Group Description

Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)

Tolvaptan

Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)

Furosemide

Period Title: Overall Study
Started 18 15
Completed 18 15
Not Completed 0 0
Arm/Group Title Tolvaptan Furosemide Total
Hide Arm/Group Description

Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)

Tolvaptan

Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)

Furosemide

Total of all reporting groups
Overall Number of Baseline Participants 18 15 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 15 participants 33 participants
53  (11.7) 59  (8.9) 56  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 15 participants 33 participants
Female
7
  38.9%
1
   6.7%
8
  24.2%
Male
11
  61.1%
14
  93.3%
25
  75.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 15 participants 33 participants
18 15 33
Home Loop Diuretic Dose (Furosemide equivalents)  
Mean (Standard Deviation)
Unit of measure:  Mg
Number Analyzed 18 participants 15 participants 33 participants
93  (63.5) 108  (77.5) 100  (68.5)
1.Primary Outcome
Title Median Urine Output at 24 Hours Post Randomization
Hide Description [Not Specified]
Time Frame 24 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tolvaptan Furosemide
Hide Arm/Group Description:

Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)

Tolvaptan

Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)

Furosemide

Overall Number of Participants Analyzed 18 15
Median (Inter-Quartile Range)
Unit of Measure: mL
2910
(1100 to 4225)
3150
(2375 to 5680)
2.Secondary Outcome
Title Median Change in Serum Creatinine at 24 Hours Post Randomization
Hide Description Comparison between baseline and 24 hours post randomization concentrations.
Time Frame 24 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tolvaptan Furosemide
Hide Arm/Group Description:

Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)

Tolvaptan

Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)

Furosemide

Overall Number of Participants Analyzed 18 15
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Median Scr at Baseline
1.15
(0.88 to 1.51)
0.87
(0.76 to 1.22)
Median Scr at 24h
1.06
(0.76 to 1.37)
0.96
(-0.19 to 1.53)
Median 24h Change
-0.08
(-0.14 to -0.04)
-0.01
(-0.19 to 0.15)
3.Other Pre-specified Outcome
Title Total Urine Output
Hide Description [Not Specified]
Time Frame Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Glomerular Filtration Rate (Estimated)
Hide Description [Not Specified]
Time Frame Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title In-hospital Mortality
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Mean Hourly Urine Output at 24 Hours
Hide Description [Not Specified]
Time Frame Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Serum Sodium Change
Hide Description Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.
Time Frame Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Weight Change
Hide Description Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.
Time Frame Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Cumulative Furosemide Dose
Hide Description [Not Specified]
Time Frame Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Cumulative Metolazone Use
Hide Description [Not Specified]
Time Frame Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Change in Self-rated Dyspnea
Hide Description [Not Specified]
Time Frame At baseline, 24 and 96 hours post randomization
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Acute Worsening of Kidney Function (Defined as an Increase in Serum Creatinine 0.3 mg/dL or 25% Above Baseline)
Hide Description [Not Specified]
Time Frame Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Incidence of Electrolyte Abnormalities
Hide Description Hypo- and hyperkalemia defined as outside the range of 3.5 to 5.0 mEq/L Hypo- and hypermagnesemia defined as outside the range of 1.5-2.4 mEq/L
Time Frame Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Symptomatic Hypotension
Hide Description [Not Specified]
Time Frame Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
15.Other Pre-specified Outcome
Title Change in Plasma Renin Activity
Hide Description [Not Specified]
Time Frame At baseline, 24 and 96 hours post randomization
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Change in Copeptin
Hide Description [Not Specified]
Time Frame At baseline, 24 and 96 hours post randomization
Outcome Measure Data Not Reported
17.Other Pre-specified Outcome
Title Change in N-terminal Pro-B-type Natriuretic Peptide
Hide Description [Not Specified]
Time Frame At baseline, 24 and 96 hours post randomization
Outcome Measure Data Not Reported
18.Other Pre-specified Outcome
Title Change in Cystatin C
Hide Description [Not Specified]
Time Frame At baseline, 24 and 96 hours post randomization
Outcome Measure Data Not Reported
19.Other Pre-specified Outcome
Title Change in Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL)
Hide Description [Not Specified]
Time Frame At baseline, 24, 48, 72 and 96 hours post randomization
Outcome Measure Data Not Reported
20.Other Pre-specified Outcome
Title Hospital Length of Stay
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 5 days
Outcome Measure Data Not Reported
Time Frame During hospitalization (up to 96 hours post randomization)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tolvaptan Furosemide
Hide Arm/Group Description

Tolvaptan 30-60mg once daily (with rescue loop diuretic or metolazone)

Tolvaptan

Furosemide continuous infusion 5mg/h with option to titrate (with rescue metolazone)

Furosemide

All-Cause Mortality
Tolvaptan Furosemide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Tolvaptan Furosemide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tolvaptan Furosemide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Tien Ng, Pharm.D.
Organization: University of Southern California School of Pharmacy
Phone: 3234421840
EMail: tienng@usc.edu
Layout table for additonal information
Responsible Party: Tien Ng, University of Southern California
ClinicalTrials.gov Identifier: NCT02183792     History of Changes
Other Study ID Numbers: HS-13-00705
First Submitted: June 25, 2014
First Posted: July 8, 2014
Results First Submitted: May 2, 2019
Results First Posted: May 27, 2019
Last Update Posted: May 27, 2019