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RECRUITING

NCT06898515

PHASE3

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

Sponsor: Reprieve Cardiovascular, Inc

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-07-14

Completion Date

2027-12

Last Updated

2025-11-26

Healthy Volunteers

Conditions

Acute Decompensated Heart Failure

Interventions

DEVICE

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.

DRUG

furosemide infusion

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

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.

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