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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Device: Reprieve System; Drug: furosemide infusion

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Annemarie Forrest; Phone Number: 617-848-0400; Email: aforrest@reprievecardio.com

Study Locations

• Germany
  • Giessen, Germany, 35392
    • Recruiting
    • Universitätsklinikum Gießen (UKGM)
  • Hanover, Germany, 30625
    • Recruiting
    • Hannover University Hospital
  • Heidelberg, Germany
    • Recruiting
    • University Hospital Heidelberg
  • Jena, Germany, 07747
    • Not yet recruiting
    • Jena University Hospital
• Italy
  • Ancona, Italy, 60121
    • Not yet recruiting
    • Universitaria delle Marche
  • Bergamo, Italy, 24127
    • Not yet recruiting
    • ASST Azienda Ospedaliera Papa Giovanni XXIII
  • Milan, Italy, 20162
    • Not yet recruiting
    • ASST Niguarda Great Metropolitan Hospital
• Poland
  • Bialystok, Poland, 15-089
    • Recruiting
    • Medical University of Białystok
  • Lodz, Poland, 70445
    • Recruiting
    • Medical University of Lodz
  • Wroclaw, Poland, 45573
    • Recruiting
    • University Hospital Wroclaw
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Vall d'Hebron University Hospital
  • Barcelona, Spain, 08907
    • Recruiting
    • Hospital De Bellvitge
  • Madrid, Spain, 28222
    • Recruiting
    • Puerta de Hierro Majadahonda University Hospital
  • Madrid, Spain, 28000
    • Recruiting
    • Hospital Ramon y Cajal
  • Valencia, Spain, 46000
    • Recruiting
    • Clínico Universitario de Valencia
  • Valencia, Spain, 46000
    • Recruiting
    • Hospital General Valencia
• United States
  • California
    • Irvine, California, United States, 92697
      • Recruiting
      • University of California Irvine
    • La Jolla, California, United States, 92037
      • Not yet recruiting
      • Scripps Memorial Hospital
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Medical Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont Atlanta Hospital
    • Augusta, Georgia, United States, 30901
      • Recruiting
      • Piedmont Augusta Hospital
    • Gainesville, Georgia, United States, 30501
      • Recruiting
      • Northeast Georgia Medical Center
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Not yet recruiting
      • Advocate Christ Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • Recruiting
      • University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Not yet recruiting
      • University of Louisville Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48197
      • Recruiting
      • Trinity Health Ann Arbor Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Corewell Health Butterworth Hospital
    • Royal Oak, Michigan, United States, 48073
      • Recruiting
      • Corewell William Beaumont University Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute
  • Mississippi
    • Jackson, Mississippi, United States, 38677
      • Recruiting
      • University of Mississippi
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Not yet recruiting
      • Harry S. Truman Veteran's Memorial Hospital
    • St Louis, Missouri, United States, 63130
      • Recruiting
      • Washington University
    • St Louis, Missouri, United States, 63130
      • Recruiting
      • St. Louis VA
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Not yet recruiting
      • Duke University
    • Greensboro, North Carolina, United States, 27401
      • Not yet recruiting
      • Moses H. Cone Memorial Hospital
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • Recruiting
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • Lindner Center at Christ Hospital
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • UH Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Recruiting
      • Oklahoma Heart Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 191904
      • Recruiting
      • University of Pennsylvania
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health Greenville Memorial Hospital
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott and White
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann-Texas Medical Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine Ben Taub Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova Fairfax Medical Campus
    • Richmond, Virginia, United States, 23219
      • Recruiting
      • VCU Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • UW Harborview
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Not yet recruiting
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reprieve System; Participants randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.	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.
Active Comparator: Optimal Diuretic Therapy (ODT); Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy	Drug: furosemide infusion; Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy
No Intervention: Registry; Participants will be treated per local site usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hierarchical composite/win-ratio	Freedom from 30-day CV mortality; Freedom from HF Rehospitalization 30 days post-discharge; Greater net sodium loss per 24 hours during treatment	1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization
Incidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI)	KDIGO stage 2 or greater AKI: ≥ doubling of serum creatinine or use of renal replacement therapy; CAUTI per CDC definition	initiation of randomized therapy through 72 hours following completion of randomized therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CV mortality and cumulative HF rehospitalizations	Both types of events will be combined in a total "event rate" compared between groups	90 days after hospital discharge
Time on IV diuretic therapy		randomization through hospital discharge, assessed up to 30 days
Net sodium loss		per 24 hours at end of randomized therapy
Net fluid loss	Fluid input subtracted from total urine output	per 24 hours at end of randomized therapy
Weight loss		per 24 hours at end of randomized therapy
Hypotension defined as systolic blood pressure < 80 mmHg documented with two readings at least 30 minutes apart with symptoms (e.g., chest pain, dizziness) or <80 mmHg requiring an intervention including IV fluids or vasopressors.		initiation of randomized therapy up to 12 hours after stopping randomized therapy
Severe electrolyte abnormality	serum potassium <3.0 mEq/L with ≥ 0.5 mEq/L decrease from initiation of randomized therapy, magnesium <1.3 mEq/L with ≥0.5 mEq/L decrease from initiation of randomized therapy, or sodium <125 mEq/L with ≥ 5.0 mEq/L decrease from initiation of randomized therapy	initiation of randomized therapy up to 72 hours after stopping randomized therapy
Worsening heart failure requiring a higher level of HF therapy		initiation of randomized therapy up to 72 hours after stopping randomized therapy
Tinnitus or hearing loss lasting more than 30 minutes		initiation of randomized therapy up to 12 hours after stopping randomized therapy
Time to discharge readiness	Time from initiation of randomized therapy to when the participant becomes medically ready for discharge from a decompensated heart failure treatment standpoint	through hospital discharge, an average of 5 days
Length of stay	Time from initiation of randomized therapy to hospital discharge	through hospital discharge, an average of 5 days

Collaborators and Investigators

• Sponsor: Reprieve Cardiovascular, Inc
• Investigators: Principal Investigator: Javed Butler, MD, MPH, MBA, Baylor Scott and White Health

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Diuretics; Natriuretic Agents; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: IDE-G210258-CLN0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No