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Recruiting Phase 3

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

NCT06898515 · tracked via the Priya Life Science Italy tracker
Sponsor
Reprieve Cardiovascular, Inc
Phase
Phase 3
Started
2025-07-14
Last updated
2026-10-08

Condition(s) studied

Acute Decompensated Heart Failure

Investigational drug(s) / intervention(s)

Reprieve Systemfurosemide infusion →

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.

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

Study 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

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Hierarchical composite/win-ratio — 1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization
    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
  • Incidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI) — initiation of randomized therapy through 72 hours following completion of randomized therapy
    KDIGO stage 2 or greater AKI: ≥ doubling of serum creatinine or use of renal replacement therapy; CAUTI per CDC definition

Trial sites (50)

FacilityCityRegionStatus
University of California Irvine Irvine California Recruiting
Memorial Care Long Beach Long Beach California Recruiting
UC Davis Medical Center Sacramento California Recruiting
University of Florida Gainesville Florida Recruiting
Piedmont Atlanta Hospital Atlanta Georgia Recruiting
Wellstar Hospital Atlanta Georgia Recruiting
Piedmont Augusta Hospital Augusta Georgia Recruiting
Northeast Georgia Medical Center Gainesville Georgia Recruiting
Advocate Christ Medical Center Oak Lawn Illinois Not Yet Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
University of Louisville Hospital Louisville Kentucky Recruiting
Trinity Health Ann Arbor Hospital Ann Arbor Michigan Recruiting
Corewell Health Butterworth Hospital Grand Rapids Michigan Recruiting
Corewell William Beaumont University Hospital Royal Oak Michigan Recruiting
Minneapolis Heart Institute Minneapolis Minnesota Recruiting
University of Mississippi Jackson Mississippi Recruiting
St. Louis VA St Louis Missouri Recruiting
Washington University St Louis Missouri Recruiting
Duke University Durham North Carolina Recruiting
Moses H. Cone Memorial Hospital Greensboro North Carolina Recruiting
Atrium Health Wake Forest Baptist Medical Center Winston-Salem North Carolina Recruiting
Lindner Center at Christ Hospital Cincinnati Ohio Recruiting
UH Cleveland Medical Center Cleveland Ohio Recruiting
Ohio State University Hospital Columbus Ohio Recruiting
Oklahoma Heart Hospital Oklahoma City Oklahoma Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
Prisma Health Greenville Memorial Hospital Greenville South Carolina Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Baylor Scott and White Dallas Texas Recruiting
Baylor College of Medicine Ben Taub Hospital Houston Texas Recruiting
Houston Methodist Houston Texas Recruiting
Memorial Hermann-Texas Medical Center Houston Texas Recruiting
Inova Fairfax Medical Campus Falls Church Virginia Recruiting
VCU Medical Center Richmond Virginia Recruiting
Aurora St. Luke's Medical Center Milwaukee Wisconsin Recruiting
Universitätsklinikum Gießen (UKGM) Giessen Germany Recruiting
Hannover University Hospital Hanover Germany Recruiting
University Hospital Heidelberg Heidelberg Germany Recruiting
Universitaria delle Marche Ancona Italy Recruiting
ASST Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy Recruiting

+ 10 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06898515 on ClinicalTrials.gov ↗ ← All trials in Italy