RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Reprieve Cardiovascular, Inc • ClinicalTrials.gov ID: NCT06898515

Registry updated: 2026-10-13

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Description

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.

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.
furosemide infusion (Drug)
Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy

Eligibility criteria

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.

Conditions

Acute Decompensated Heart Failure

Locations

University of California Irvine — Irvine, California, United States
Memorial Care Long Beach — Long Beach, 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
Wellstar 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
St. Louis VA — St Louis, Missouri, United States
Washington University — St Louis, Missouri, 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
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
Vanderbilt University Medical Center — Nashville, Tennessee, United States
Baylor Scott and White — Dallas, Texas, United States
Baylor College of Medicine Ben Taub Hospital — Houston, Texas, United States
Houston Methodist — 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
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
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

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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