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NCT06898515PHASE3Recruiting

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

Reprieve Cardiovascular, Inc

Start Date

7/14/2025

Completion Date

12/1/2027

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 Criteria

Age Range: 22 years to No maximum

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.

Interventions

DEVICE

Reprieve System

DRUG

furosemide infusion

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Conditions

Acute Decompensated Heart Failure

Locations

University of California Irvine

Irvine, California 92697

United States

Scripps Memorial Hospital

La Jolla, California 92037

United States

UC Davis Medical Center

Sacramento, California 95817

United States

University of Florida

Gainesville, Florida 32610

United States

Piedmont Atlanta Hospital

Atlanta, Georgia 30309

United States

Piedmont Augusta Hospital

Augusta, Georgia 30901

United States

Northeast Georgia Medical Center

Gainesville, Georgia 30501

United States

Advocate Christ Medical Center

Oak Lawn, Illinois 60453

United States

University of Kansas Medical Center

Kansas City, Kansas 66103

United States

University of Louisville Hospital

Louisville, Kentucky 40202

United States

Trinity Health Ann Arbor Hospital

Ann Arbor, Michigan 48197

United States

Corewell Health Butterworth Hospital

Grand Rapids, Michigan 49503

United States

Corewell William Beaumont University Hospital

Royal Oak, Michigan 48073

United States

Minneapolis Heart Institute

Minneapolis, Minnesota 55407

United States

University of Mississippi

Jackson, Mississippi 38677

United States

Harry S. Truman Veteran's Memorial Hospital

Columbia, Missouri 65201

United States

St. Louis VA

St Louis, Missouri 63130

United States

Washington University

St Louis, Missouri 63130

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Stony Brook University Hospital

Stony Brook, New York 11794

United States

Duke University

Durham, North Carolina 27710

United States

Moses H. Cone Memorial Hospital

Greensboro, North Carolina 27401

United States

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina 27157

United States

Lindner Center at Christ Hospital

Cincinnati, Ohio 45219

United States

University of Cincinnati

Cincinnati, Ohio 45221

United States

UH Cleveland Medical Center

Cleveland, Ohio 44106

United States

Ohio State University Hospital

Columbus, Ohio 43210

United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma 73120

United States

University of Pennsylvania

Philadelphia, Pennsylvania 191904

United States

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina 29605

United States

Baylor Scott and White

Dallas, Texas 75246

United States

Baylor College of Medicine Ben Taub Hospital

Houston, Texas 77030

United States

Memorial Hermann-Texas Medical Center

Houston, Texas 77030

United States

Inova Fairfax Medical Campus

Falls Church, Virginia 22042

United States

VCU Medical Center

Richmond, Virginia 23219

United States

UW Harborview

Seattle, Washington 98104

United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin 53215

United States

Universitätsklinikum Gießen (UKGM)

Giessen, 35392

Germany

Hannover University Hospital

Hanover, 30625

Germany

University Hospital Heidelberg

Heidelberg,

Germany

Jena University Hospital

Jena, 07747

Germany

Universitaria delle Marche

Ancona, 60121

Italy

ASST Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127

Italy

ASST Niguarda Great Metropolitan Hospital

Milan, 20162

Italy

Medical University of Białystok

Bialystok, 15-089

Poland

Medical University of Lodz

Lodz, 70445

Poland

University Hospital Wroclaw

Wroclaw, 45573

Poland

Vall d'Hebron University Hospital

Barcelona, 08035

Spain

Hospital de Bellvitge

Barcelona, 08907

Spain

Hospital Ramon y Cajal

Madrid, 28000

Spain

Puerta de Hierro Majadahonda University Hospital

Madrid, 28222

Spain

Clínico Universitario de Valencia

Valencia, 46000

Spain

Hospital General Valencia

Valencia, 46000

Spain