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

Part of paid clinical trials in Irvine, California.

Sponsor
Reprieve Cardiovascular, Inc
Study ID
NCT06898515
Phase
PHASE3
Status
Recruiting
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Conditions

  • Acute Decompensated Heart Failure

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jul 14, 2025
Status verified
Nov 2025
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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
  • No Intervention: Registry
    Participants will be treated per local site usual care.

Primary Outcome Measure

Hierarchical composite/win-ratio [ Time Frame: 1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization ]

Central Contacts

Locations (37)

FacilityCityStateZIPSite coordinators
University of California IrvineIrvineCalifornia92697-
Scripps Memorial HospitalLa JollaCalifornia92037-
UC Davis Medical CenterSacramentoCalifornia95817-
University of FloridaGainesvilleFlorida32610-
Piedmont Atlanta HospitalAtlantaGeorgia30309-
Piedmont Augusta HospitalAugustaGeorgia30901-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Advocate Christ Medical CenterOak LawnIllinois60453-
University of Kansas Medical CenterKansas CityKansas66103-
University of Louisville HospitalLouisvilleKentucky40202-
Trinity Health Ann Arbor HospitalAnn ArborMichigan48197-
Corewell Health Butterworth HospitalGrand RapidsMichigan49503-
Corewell William Beaumont University HospitalRoyal OakMichigan48073-
Minneapolis Heart InstituteMinneapolisMinnesota55407-
University of MississippiJacksonMississippi38677-
Harry S. Truman Veteran's Memorial HospitalColumbiaMissouri65201-
St. Louis VASt LouisMissouri63130-
Washington UniversitySt LouisMissouri63130-
University of Nebraska Medical CenterOmahaNebraska68198-
Stony Brook University HospitalStony BrookNew York11794-
Duke UniversityDurhamNorth Carolina27710-
Moses H. Cone Memorial HospitalGreensboroNorth Carolina27401-
Atrium Health Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
Lindner Center at Christ HospitalCincinnatiOhio45219-
University of CincinnatiCincinnatiOhio45221-
UH Cleveland Medical CenterClevelandOhio44106-
Ohio State University HospitalColumbusOhio43210-
Oklahoma Heart HospitalOklahoma CityOklahoma73120-
University of PennsylvaniaPhiladelphiaPennsylvania191904-
Prisma Health Greenville Memorial HospitalGreenvilleSouth Carolina29605-
Baylor Scott and WhiteDallasTexas75246-
Baylor College of Medicine Ben Taub HospitalHoustonTexas77030-
Memorial Hermann-Texas Medical CenterHoustonTexas77030-
Inova Fairfax Medical CampusFalls ChurchVirginia22042-
VCU Medical CenterRichmondVirginia23219-
UW HarborviewSeattleWashington98104-
Aurora St. Luke's Medical CenterMilwaukeeWisconsin53215-

Find similar trials in Irvine, CA

By research site
University of California Irvine· Irvine, CAScripps Memorial Hospital· La Jolla, CAUC Davis Medical Center· Sacramento, CAUniversity of Florida· Gainesville, FLPiedmont Atlanta Hospital· Atlanta, GAPiedmont Augusta Hospital· Augusta, GA

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