Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

NCT06898515 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: IDE-G210258-CLN0002
• Study Type: interventional
• Target: 400
• Locations: 5 countries
• Sites: 53

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

Outcome Measures

Primary Outcomes (2)

• Hierarchical composite/win-ratio

  1. Freedom from 30-day CV mortality 2. Freedom from HF Rehospitalization 30 days post-discharge 3. Greater net sodium loss per 24 hours during treatment

  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)

  KDIGO stage 2 or greater AKI: ≥ doubling of serum creatinine or use of renal replacement therapy; CAUTI per CDC definition

  initiation of randomized therapy through 72 hours following completion of randomized therapy

Secondary Outcomes (11)

• Net sodium loss

  per 24 hours at end of randomized therapy

• Time to discharge readiness

  through hospital discharge, an average of 5 days

• Time on IV diuretic therapy

  randomization through hospital discharge, assessed up to 30 days

• Net fluid loss

  per 24 hours at end of randomized therapy

• Weight loss

  per 24 hours at end of randomized therapy

Study Arms (3)

Reprieve System

EXPERIMENTAL

Participants 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 System

Optimal Diuretic Therapy (ODT)

ACTIVE COMPARATOR

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

Drug: furosemide infusion

Registry

NO INTERVENTION

Participants will be treated per local site usual care.

Interventions

Reprieve System DEVICE

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.

Reprieve System

furosemide infusion DRUG

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

Optimal Diuretic Therapy (ODT)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider.
• Current outpatient prescription for daily loop diuretic.
• Participants ≥ 22 years of age able to provide informed consent and comply with study procedures.
• 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

You may not qualify if:

• 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.
• 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.
• Uncontrolled arrhythmias defined as sustained HR \>130 beats/min for \>10 minutes within the past 48 hours.
• Severe lung disease with chronic home oxygen requirement \>2L/min.
• Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
• 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).
• 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.
• 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
• Currently enrolled in an interventional trial (observational studies are permitted).
• Life expectancy less than 6 months.
• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• Reprieve Cardiovascular, Inc: lead

Study Sites (53)

University of California Irvine

Irvine, California, 92697, United States

RECRUITING

Scripps Memorial Hospital

La Jolla, California, 92037, United States

NOT YET RECRUITING

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

RECRUITING

Piedmont Augusta Hospital

Augusta, Georgia, 30901, United States

RECRUITING

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

RECRUITING

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

NOT YET RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

RECRUITING

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

Trinity Health Ann Arbor Hospital

Ann Arbor, Michigan, 48197, United States

RECRUITING

Corewell Health Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Corewell William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

RECRUITING

University of Mississippi

Jackson, Mississippi, 38677, United States

RECRUITING

Harry S. Truman Veteran's Memorial Hospital

Columbia, Missouri, 65201, United States

NOT YET RECRUITING

St. Louis VA

St Louis, Missouri, 63130, United States

RECRUITING

Washington University

St Louis, Missouri, 63130, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, 27401, United States

NOT YET RECRUITING

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Lindner Center at Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45221, United States

RECRUITING

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Ohio State University Hospital

Columbus, Ohio, 43210, United States

RECRUITING

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 191904, United States

RECRUITING

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

RECRUITING

Baylor Scott and White

Dallas, Texas, 75246, United States

RECRUITING

Baylor College of Medicine Ben Taub Hospital

Houston, Texas, 77030, United States

RECRUITING

Memorial Hermann-Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

RECRUITING

VCU Medical Center

Richmond, Virginia, 23219, United States

RECRUITING

UW Harborview

Seattle, Washington, 98104, United States

RECRUITING

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

NOT YET RECRUITING

Universitätsklinikum Gießen (UKGM)

Giessen, 35392, Germany

RECRUITING

Hannover University Hospital

Hanover, 30625, Germany

RECRUITING

University Hospital Heidelberg

Heidelberg, Germany

RECRUITING

Jena University Hospital

Jena, 07747, Germany

NOT YET RECRUITING

Universitaria delle Marche

Ancona, 60121, Italy

NOT YET RECRUITING

ASST Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127, Italy

NOT YET RECRUITING

ASST Niguarda Great Metropolitan Hospital

Milan, 20162, Italy

NOT YET RECRUITING

Medical University of Białystok

Bialystok, 15-089, Poland

RECRUITING

Medical University of Lodz

Lodz, 70445, Poland

RECRUITING

University Hospital Wroclaw

Wroclaw, 45573, Poland

RECRUITING

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

RECRUITING

Hospital de Bellvitge

Barcelona, 08907, Spain

RECRUITING

Hospital Ramon y Cajal

Madrid, 28000, Spain

RECRUITING

Puerta de Hierro Majadahonda University Hospital

Madrid, 28222, Spain

RECRUITING

Clínico Universitario de Valencia

Valencia, 46000, Spain

RECRUITING

Hospital General Valencia

Valencia, 46000, Spain

RECRUITING

Study Officials

• Javed Butler, MD, MPH, MBA

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annemarie Forrest

CONTACT

617-848-0400; aforrest@reprievecardio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 27, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); US (37); DE (4); PL (3); ES (6)