Recruiting
Phase 3

Reprieve System vs. ODT

Sponsor:

Reprieve Cardiovascular, Inc

Code:

NCT06898515

Conditions

Acute Decompensated Heart Failure

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Reprieve System

furosemide infusion

Study Details

Brief summary:

The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve 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 System can more efficiently decongest ADHF patients in comparison to Control Therapy.

Conditions

Acute Decompensated Heart Failure

Study ID

NCT06898515

Start date

Jul 14, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of HF with expected hospitalization >24 hours, with >1 new or worsening symptom and >2 physical examination, laboratory, or invasive findings of HF, and receiving or with plans to receive a HF-specific treatment
2. ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider.
3. Current outpatient prescription for daily loop diuretic.
4. Participants ≥ 22 years of age able to provide informed consent and comply with study procedures.
5. Elevated risk of diuretic resistance, as indicated by at least one of the following: Baseline hypochloremia OR Urine output <1L in the 6 hours following IV loop diuretic >=40 mg furosemide equivalent OR Spot urine sodium <100 mmol/L 1-2 hours after IV loop diuretic >= 40 mg furosemide equivalent

Exclusion Criteria:

1. Urologic issues that would predispose the participant to a high rate of urogenital trauma or infection with catheter placement or known inability to place a Foley catheter.
2. Hemodynamic instability as defined by any of the following: sustained systolic blood pressure <90 mmHg for >15 minutes within the past 48 hours, use of IV vasopressors or inotropes within past 48 hours, and/or current or previous mechanical circulatory support within the last week.
3. Uncontrolled arrhythmias defined as sustained HR >130 beats/min for >10 minutes within the past 48 hours.
4. Severe lung disease with chronic home oxygen requirement >2L/min.
5. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
6. Estimated glomerular filtration rate (eGFR) <25 ml/min/1.73m2 (calculated with either MDRD or CKD-EPI) or current use of renal replacement therapy (RRT).
7. Significant left ventricular outflow obstruction, severe uncorrected complex congenital heart disease, known severe stenotic valvular disease, severe infiltrative or constrictive cardiomyopathy or other diagnosis that would make aggressive decongestion unsafe.
8. Current or recent (< 30 days) type I myocardial infarction (e.g., acute coronary syndrome such as NSTEMI or STEMI from plaque rupture), coronary artery bypass surgery, or stroke. An isolated troponin elevation (e.g., from volume overload or demand ischemia) is not a reason for exclusion.
9. Severe electrolyte abnormalities (e.g., serum potassium <3.0 mEq/L, magnesium <1.3 mEq/L or sodium <125 mEq/L). Note: These are based on baseline/screening labs. Participants whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial.
10. Other concomitant disease or condition the investigator believes will make it difficult to follow instructions or comply with study procedures and/or follow-up visits, including expected prolonged hospitalization for reasons other than decongestive therapy
11. Currently enrolled in an interventional trial (observational studies are permitted).
12. Life expectancy less than 6 months.
13. Women who are pregnant or breastfeeding.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Reprieve System

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

active comparator: Optimal Diuretic Therapy (ODT)

Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy

no intervention: Registry

Participants will be treated per local site usual care.

Interventions

Reprieve System

The Reprieve System 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.

furosemide infusion

Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy

Primary outcome measure

  • Hierarchical composite/win-ratio [ Time Frame: 1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization ]
  • Incidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI) [ Time Frame: initiation of randomized therapy through 72 hours following completion of randomized therapy ]

Central Contacts and Locations

Central contacts

Locations

University of California Irvine

Recruiting

Irvine, California, United States, 92697

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Piedmont Atlanta Hospital

Recruiting

Atlanta, Georgia, United States, 30309

Piedmont Augusta Hospital

Recruiting

Augusta, Georgia, United States, 30901

Northeast Georgia Medical Center

Recruiting

Gainesville, Georgia, United States, 30501

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66103

Trinity Health Ann Arbor Hospital

Recruiting

Ann Arbor, Michigan, United States, 48197

Corewell Health Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Corewell William Beaumont University Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Minneapolis Heart Institute

Recruiting

Minneapolis, Minnesota, United States, 55407

University of Mississippi

Recruiting

Jackson, Mississippi, United States, 38677

St. Louis VA

Recruiting

St Louis, Missouri, United States, 63130

Washington University

Recruiting

St Louis, Missouri, United States, 63130

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Atrium Health Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Lindner Center at Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45221

UH Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Ohio State University Hospital

Recruiting

Columbus, Ohio, United States, 43210

Oklahoma Heart Hospital

Recruiting

Oklahoma City, Oklahoma, United States, 73120

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 191904

Prisma Health Greenville Memorial Hospital

Recruiting

Greenville, South Carolina, United States, 29605

Baylor Scott and White

Recruiting

Dallas, Texas, United States, 75246

Baylor College of Medicine Ben Taub Hospital

Recruiting

Houston, Texas, United States, 77030

Memorial Hermann-Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Inova Fairfax Medical Campus

Recruiting

Falls Church, Virginia, United States, 22042

VCU Medical Center

Recruiting

Richmond, Virginia, United States, 23219

UW Harborview

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

Reprieve Cardiovascular, Inc

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Reprieve Cardiovascular, Inc on 2025-11-26.