N/A
N=100
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)
Acute Decompensated Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT05174312 ↗Enrolled (actual)
100
Serious AEs
54.2%
Results posted
May 2026
Primary outcome: Primary: Total Urine Sodium Output — 1082; 423 mmol of sodium — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reprieve Decongestion Management System (Device); Diuretic (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Reprieve Cardiovascular, Inc
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Urine Sodium Output |
1082; 423 | <0.001 sig |
| PRIMARY Clinically Significant Acute Kidney Injury, Severe Electrolyte Abnormality, Symptomatic Hypotension or Hypertensive Emergency. |
16; 19 | 0.43 |
| SECONDARY Net Fluid Loss |
8.1; 8.1 | — |
| SECONDARY Time on IV Loop Diuretics |
46; 88 | — |
Summary
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS can more efficiently decongest ADHF patients in comparison to Control Therapy.
Eligibility Criteria
Inclusion Criteria
- Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign.
- ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
- Prior use of loop diuretics within 30 says prior to admission.
- ≥ 18 years of age able to provide informed consent and comply with study procedures.
Exclusion Criteria
- Inability to place Foley catheter or IV catheter.
- Hemodynamic instability.
- Dyspnea due primarily to non-cardiac causes.
- Acute infection with evidence of systemic involvement.
- Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.
- Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment, or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.
- Inability to follow instructions or comply with follow-up procedures.
- Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.
- Severe electrolyte abnormalities.
- Presence of active coronavirus disease 2019 (COVID-19) infection.
- Enrollment in another interventional trial during the index hospitalization.
- Inability to return for follow-up study visits.
- Life expectancy less than 3 months.
- Women who are pregnant or intend to become pregnant.
Data sourced from ClinicalTrials.gov (NCT05174312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.