RecruitingPhase 3NCT06898515

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

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

Sponsor

Reprieve Cardiovascular, Inc

Enrollment

400 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Decompensated Heart Failure

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.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device called the Reprieve System, which uses a small catheter placed in the bladder to help remove excess fluid from people hospitalized with acute decompensated heart failure — a condition where the heart suddenly cannot pump effectively, causing dangerous fluid buildup in the body. Standard treatment uses diuretic medications (water pills), but some patients don't respond well. This device aims to help drain excess fluid more reliably in those difficult cases. **You may be eligible if...** - You are 22 years or older - You have been hospitalized with worsening heart failure symptoms - You are at least 10 pounds above your normal (dry) weight due to fluid buildup - You have a daily prescription for a loop diuretic (such as furosemide) at home - You show signs of diuretic resistance (poor response to IV water pills, or low urine sodium levels) **You may NOT be eligible if...** - You have urologic problems that would make bladder catheter placement unsafe or prone to infection - You have very unstable blood pressure or require IV medications to support your heart function - You are in kidney failure requiring dialysis - You have had a recent heart attack, major heart surgery, or heart rhythm device implantation - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEReprieve 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.

DRUGfurosemide infusion

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

Locations(53)

University of California Irvine

Irvine, California, United States

Scripps Memorial Hospital

La Jolla, California, United States

UC Davis Medical Center

Sacramento, California, United States

University of Florida

Gainesville, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Piedmont Augusta Hospital

Augusta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Louisville Hospital

Louisville, Kentucky, United States

Trinity Health Ann Arbor Hospital

Ann Arbor, Michigan, United States

Corewell Health Butterworth Hospital

Grand Rapids, Michigan, United States

Corewell William Beaumont University Hospital

Royal Oak, Michigan, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

University of Mississippi

Jackson, Mississippi, United States

Harry S. Truman Veteran's Memorial Hospital

Columbia, Missouri, United States

St. Louis VA

St Louis, Missouri, United States

Washington University

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Duke University

Durham, North Carolina, United States

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, United States

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Lindner Center at Christ Hospital

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

UH Cleveland Medical Center

Cleveland, Ohio, United States

Ohio State University Hospital

Columbus, Ohio, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Baylor Scott and White

Dallas, Texas, United States

Baylor College of Medicine Ben Taub Hospital

Houston, Texas, United States

Memorial Hermann-Texas Medical Center

Houston, Texas, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

VCU Medical Center

Richmond, Virginia, United States

UW Harborview

Seattle, Washington, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Universitätsklinikum Gießen (UKGM)

Giessen, Germany

Hannover University Hospital

Hanover, Germany

University Hospital Heidelberg

Heidelberg, Germany

Jena University Hospital

Jena, Germany

Universitaria delle Marche

Ancona, Italy

ASST Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

ASST Niguarda Great Metropolitan Hospital

Milan, Italy

Medical University of Białystok

Bialystok, Poland

Medical University of Lodz

Lodz, Poland

University Hospital Wroclaw

Wroclaw, Poland

Vall d'Hebron University Hospital

Barcelona, Spain

Hospital de Bellvitge

Barcelona, Spain

Hospital Ramon y Cajal

Madrid, Spain

Puerta de Hierro Majadahonda University Hospital

Madrid, Spain

Clínico Universitario de Valencia

Valencia, Spain

Hospital General Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06898515

Related Trials

Reprieve System Pilot Study

NCT062727341 location

Add-on Diuretics in Acute Decompensated Heart Failure

NCT073720401 location

Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Acute Decompensated Heart Failure

NCT071990881 location

EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

NCT061619871 location

Circulating Markers That Underlie the Transition From Compensated Hypertrophy to Heart Failure

NCT007620081 location