Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)

NCT05174312 | Completed DMC FDA Device

• 1 other identifier: RCV-0006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (2)

• Total urine sodium output

  Primary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation.

  24 hours post-treatment initiation

• Clinically significant acute kidney injury, severe electrolyte abnormality, symptomatic hypotension or hypertensive emergency.

  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.

  Through study completion, an average of 90 days

Secondary Outcomes (2)

• Net fluid loss

  End of treatment, an average of 72 hours

• Time on loop diuretics

  End of treatment, an average of 72 hours

Study Arms (2)

Reprieve Decongestion Management System

EXPERIMENTAL

Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.

Device: Reprieve Decongestion Management System

Optimal Diuretic Therapy

ACTIVE COMPARATOR

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.

Drug: Diuretic

Interventions

Reprieve Decongestion Management System DEVICE

The Reprieve Decongestion Management System, or Reprieve DMS, is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.

Reprieve Decongestion Management System

Diuretic DRUG

Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).

Optimal Diuretic Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reprieve Cardiovascular, Inc: lead

Study Sites (16)

Eastern Shore Research Institute

Fairhope, Alabama, 36532, United States

Location

University of California Irvine

Irvine, California, 92697, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Trinity Health Ann Arbor Hospital

Ypsilanti, Michigan, 48197, United States

Location

St. Louis VA

St Louis, Missouri, 63130, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Cone Health

Greensboro, North Carolina, 27401, United States

Location

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

The Lindner Research Center at Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Ohio State University Hospital

Columbus, Ohio, 43210, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health

Columbia, South Carolina, 29203, United States

Location

Ascension Texas Cardiovascular

Austin, Texas, 78705, United States

Location

Baylor Scott & White

Dallas, Texas, 75246, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Interventions

Diuretics

Intervention Hierarchy (Ancestors)

Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 30, 2021
• Study Start: July 11, 2022
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)