Trial Outcomes & Findings for Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (NCT NCT05174312)
NCT ID: NCT05174312
Last Updated: 2026-05-29
Results Overview
Primary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
24 hours post-treatment initiation
Results posted on
2026-05-29
Participant Flow
2,216 patients were screened between July 2022 and October 2024 at 16 hospitals in the United States.
Participant milestones
| Measure |
Reprieve Decongestion Management System
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
|
Optimal Diuretic Therapy
Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
44
|
|
Overall Study
COMPLETED
|
52
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Reprieve Decongestion Management System
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
|
Optimal Diuretic Therapy
Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.
|
|---|---|---|
|
Overall Study
unable to pass urinary catheter
|
4
|
0
|
Baseline Characteristics
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)
Baseline characteristics by cohort
| Measure |
Reprieve Decongestion Management System
n=52 Participants
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
|
Optimal Diuretic Therapy
n=44 Participants
Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 13 • n=51 Participants
|
63 years
STANDARD_DEVIATION 14 • n=14 Participants
|
63 years
STANDARD_DEVIATION 14 • n=65 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=51 Participants
|
20 Participants
n=14 Participants
|
43 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=51 Participants
|
24 Participants
n=14 Participants
|
53 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=51 Participants
|
26 Participants
n=14 Participants
|
57 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Black
|
18 Participants
n=51 Participants
|
18 Participants
n=14 Participants
|
36 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
|
Serum creatinine
|
1.48 mg/dL
STANDARD_DEVIATION 0.56 • n=51 Participants
|
1.44 mg/dL
STANDARD_DEVIATION 0.56 • n=14 Participants
|
1.46 mg/dL
STANDARD_DEVIATION 0.62 • n=65 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-treatment initiationPrimary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation.
Outcome measures
| Measure |
Reprieve Decongestion Management System
n=52 Participants
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
|
Optimal Diuretic Therapy
n=44 Participants
Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.
|
|---|---|---|
|
Total Urine Sodium Output
|
1082 mmol of sodium
Standard Deviation 487
|
423 mmol of sodium
Standard Deviation 290
|
PRIMARY outcome
Timeframe: End of treatment, 0-72 hours.Primary safety endpoint includes clinically significant acute kidney injury defined as KDIGO stage 2 or greater AKI \[≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)\], severe electrolyte abnormality (serum potassium \<3.0 mEq/L, magnesium \<1.3 mEq/L or sodium \<125 mEq), symptomatic hypotension or hypertensive emergency.
Outcome measures
| Measure |
Reprieve Decongestion Management System
n=52 Participants
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
|
Optimal Diuretic Therapy
n=44 Participants
Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.
|
|---|---|---|
|
Clinically Significant Acute Kidney Injury, Severe Electrolyte Abnormality, Symptomatic Hypotension or Hypertensive Emergency.
|
16 total number of events
|
19 total number of events
|
SECONDARY outcome
Timeframe: End of treatment, 0-72 hoursDifference in the amount of net fluid removed during primary treatment
Outcome measures
| Measure |
Reprieve Decongestion Management System
n=52 Participants
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
|
Optimal Diuretic Therapy
n=44 Participants
Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.
|
|---|---|---|
|
Net Fluid Loss
|
8.1 liters
Standard Deviation 5.7
|
8.1 liters
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 0 hours through hospital dischargeTime from initiation of IV loop diuretics to discontinuation of IV loop diuretics
Outcome measures
| Measure |
Reprieve Decongestion Management System
n=52 Participants
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
|
Optimal Diuretic Therapy
n=44 Participants
Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.
|
|---|---|---|
|
Time on IV Loop Diuretics
|
46 hours
Interval 29.0 to 80.0
|
88 hours
Interval 44.0 to 143.0
|
Adverse Events
Reprieve Decongestion Management System
Serious events: 29 serious events
Other events: 44 other events
Deaths: 3 deaths
Optimal Diuretic Therapy
Serious events: 23 serious events
Other events: 35 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Reprieve Decongestion Management System
n=52 participants at risk
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
|
Optimal Diuretic Therapy
n=44 participants at risk
Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.
|
|---|---|---|
|
Nervous system disorders
Nervous system disorders
|
3.8%
2/52 • From enrollment until end of follow up, up to 90 days
|
2.3%
1/44 • From enrollment until end of follow up, up to 90 days
|
|
Psychiatric disorders
Psychiatric disorders
|
0.00%
0/52 • From enrollment until end of follow up, up to 90 days
|
4.5%
2/44 • From enrollment until end of follow up, up to 90 days
|
|
Renal and urinary disorders
Renal and urinary disorders
|
11.5%
6/52 • From enrollment until end of follow up, up to 90 days
|
18.2%
8/44 • From enrollment until end of follow up, up to 90 days
|
|
Blood and lymphatic system disorders
Blood and lymphatic disorder
|
1.9%
1/52 • From enrollment until end of follow up, up to 90 days
|
0.00%
0/44 • From enrollment until end of follow up, up to 90 days
|
|
Cardiac disorders
Cardiac disorder
|
32.7%
17/52 • From enrollment until end of follow up, up to 90 days
|
34.1%
15/44 • From enrollment until end of follow up, up to 90 days
|
|
Skin and subcutaneous tissue disorders
Administration site disorders
|
3.8%
2/52 • From enrollment until end of follow up, up to 90 days
|
9.1%
4/44 • From enrollment until end of follow up, up to 90 days
|
|
Infections and infestations
Infectious disorders
|
19.2%
10/52 • From enrollment until end of follow up, up to 90 days
|
15.9%
7/44 • From enrollment until end of follow up, up to 90 days
|
|
Injury, poisoning and procedural complications
Falls and limb injury disorders
|
5.8%
3/52 • From enrollment until end of follow up, up to 90 days
|
0.00%
0/44 • From enrollment until end of follow up, up to 90 days
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
9.6%
5/52 • From enrollment until end of follow up, up to 90 days
|
13.6%
6/44 • From enrollment until end of follow up, up to 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm disorders
|
1.9%
1/52 • From enrollment until end of follow up, up to 90 days
|
2.3%
1/44 • From enrollment until end of follow up, up to 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
3.8%
2/52 • From enrollment until end of follow up, up to 90 days
|
9.1%
4/44 • From enrollment until end of follow up, up to 90 days
|
|
Vascular disorders
Vascular disorders
|
11.5%
6/52 • From enrollment until end of follow up, up to 90 days
|
9.1%
4/44 • From enrollment until end of follow up, up to 90 days
|
Other adverse events
| Measure |
Reprieve Decongestion Management System
n=52 participants at risk
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
|
Optimal Diuretic Therapy
n=44 participants at risk
Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.
|
|---|---|---|
|
General disorders
Administration site disorders
|
1.9%
1/52 • From enrollment until end of follow up, up to 90 days
|
0.00%
0/44 • From enrollment until end of follow up, up to 90 days
|
|
General disorders
Electrolyte and fluid disorders
|
51.9%
27/52 • From enrollment until end of follow up, up to 90 days
|
43.2%
19/44 • From enrollment until end of follow up, up to 90 days
|
|
Cardiac disorders
Cardiac disorder
|
1.9%
1/52 • From enrollment until end of follow up, up to 90 days
|
0.00%
0/44 • From enrollment until end of follow up, up to 90 days
|
|
Injury, poisoning and procedural complications
Falls and limb injury disorders
|
1.9%
1/52 • From enrollment until end of follow up, up to 90 days
|
0.00%
0/44 • From enrollment until end of follow up, up to 90 days
|
|
Renal and urinary disorders
Renal and urinary disorders
|
1.9%
1/52 • From enrollment until end of follow up, up to 90 days
|
0.00%
0/44 • From enrollment until end of follow up, up to 90 days
|
|
Psychiatric disorders
Psychiatric disorders
|
0.00%
0/52 • From enrollment until end of follow up, up to 90 days
|
2.3%
1/44 • From enrollment until end of follow up, up to 90 days
|
|
Vascular disorders
Vascular disorder
|
9.6%
5/52 • From enrollment until end of follow up, up to 90 days
|
2.3%
1/44 • From enrollment until end of follow up, up to 90 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
1.9%
1/52 • From enrollment until end of follow up, up to 90 days
|
0.00%
0/44 • From enrollment until end of follow up, up to 90 days
|
|
General disorders
Other disorders
|
3.8%
2/52 • From enrollment until end of follow up, up to 90 days
|
4.5%
2/44 • From enrollment until end of follow up, up to 90 days
|
|
Infections and infestations
Catheter-associated UTI
|
1.9%
1/52 • From enrollment until end of follow up, up to 90 days
|
4.5%
2/44 • From enrollment until end of follow up, up to 90 days
|
|
General disorders
Electrolyte disorder
|
5.8%
3/52 • From enrollment until end of follow up, up to 90 days
|
0.00%
0/44 • From enrollment until end of follow up, up to 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place