Early access
Sign in
Taking people in United StatesNo phase

Tests the Reprieve System for fluid removal in acute decompensated heart failure

Compares the Reprieve System with standard diuretic drug care for fluid removal in heart failure.

Key facts

Who runs it
Reprieve Cardiovascular, Inc
Where
Ann Arbor, Atlanta, Augusta, Cincinnati, Cleveland, Columbus, Dallas, Durham, Falls Church, Gainesville, Grand Rapids, Greensboro, Greenville, Houston, Irvine, Jackson, Kansas City, Long Beach, Louisville, Milwaukee, Minneapolis, Nashville, Oak Lawn, Oklahoma City, Philadelphia, Richmond, Royal Oak, Sacramento, St Louis, and Winston-Salem, United StatesSee the 35 sitesAlso in 4 other countries, 15 sites
Trial code
Registry title
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Status
Recruiting
People taking part
400 people, planned
Started
28 Jul 2025
Expected to end
Dec 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Reprieve System
  • furosemide infusion
Record updated
13 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults in hospital with acute decompensated heart failure and extra fluid, who take a daily loop diuretic and may respond poorly to diuretics.

Age
22 years or older
Sex
All sexes
Disease stage
Heart failure with fluid build-up, expected to stay in hospital more than 24 hours. At least 10 lb (4.5 kg) above dry weight as estimated by the health care provider.
Earlier treatment
Must currently have an outpatient prescription for a daily loop diuretic.
Biomarker or test result
At least one sign of possible diuretic resistance: low blood chloride, urine output under 1 L in the 6 hours after IV loop diuretic of at least 40 mg furosemide equivalent, or spot urine sodium under 100 mmol/L 1-2 hours after that dose.

Main reasons for not taking part

  • Unstable blood pressure or heart rhythm, or recent IV vasopressors or inotropes
  • Kidney function eGFR under 25 ml/min/1.73m2 or on kidney replacement therapy
  • Heart attack, bypass surgery or stroke in the last 30 days
  • Severe electrolyte problems or acute infection affecting the whole body
  • Pregnant or breastfeeding, or life expectancy under 6 months

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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
  • ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider
  • Current outpatient prescription for daily loop diuretic
  • Participants ≥ 22 years of age able to provide informed consent and comply with study procedures
  • 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

Who cannot take part

  • 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
  • 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
  • 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
  • Uncontrolled arrhythmias defined as sustained HR >130 beats/min for >10 minutes within the past 48 hours
  • Severe lung disease with chronic home oxygen requirement >2L/min
  • 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
  • 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
  • Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count)
  • 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)
  • 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
  • Currently enrolled in an interventional trial (observational studies are permitted)
  • Life expectancy less than 6 months
  • Women who are pregnant or breastfeeding

Where in United States

Also in 4 other countries, 15 sites

  • Trinity Health Ann Arbor HospitalAnn Arbor, United StatesContact: Annemarie ForrestTaking people
  • Piedmont Atlanta HospitalAtlanta, United StatesContact: Annemarie ForrestTaking people
  • Wellstar HospitalAtlanta, United StatesContact: Annemarie ForrestTaking people
  • Piedmont Augusta HospitalAugusta, United StatesContact: Annemarie ForrestTaking people
  • Lindner Center at Christ HospitalCincinnati, United StatesContact: Annemarie ForrestTaking people
  • UH Cleveland Medical CenterCleveland, United StatesContact: Annemarie ForrestTaking people
  • Ohio State University HospitalColumbus, United StatesContact: Annemarie ForrestTaking people
  • Baylor Scott and WhiteDallas, United StatesContact: Annemarie ForrestTaking people
  • Duke UniversityDurham, United StatesContact: Annemarie ForrestTaking people
  • Inova Fairfax Medical CampusFalls Church, United StatesContact: Annemarie ForrestTaking people
  • Northeast Georgia Medical CenterGainesville, United StatesContact: Annemarie ForrestTaking people
  • University of FloridaGainesville, United StatesContact: Annemarie ForrestTaking people
  • Corewell Health - Butterworth HospitalGrand Rapids, United StatesContact: Annemarie ForrestTaking people
  • Moses H Cone Memorial HospitalGreensboro, United StatesContact: Annemarie ForrestTaking people
  • Prisma Health Greenville Memorial HospitalGreenville, United StatesContact: Annemarie ForrestTaking people
  • Baylor College of Medicine Ben Taub HospitalHouston, United StatesContact: Annemarie ForrestTaking people
  • Houston MethodistHouston, United StatesContact: Annemarie ForrestTaking people
  • Memorial Hermann Texas Medical CenterHouston, United StatesContact: Annemarie ForrestTaking people
  • University of California, IrvineIrvine, United StatesContact: Annemarie ForrestTaking people
  • University of MississippiJackson, United StatesContact: Annemarie ForrestTaking people
  • University of Kansas Medical CenterKansas City, United StatesContact: Annemarie ForrestTaking people
  • Memorial Care Long BeachLong Beach, United StatesContact: Annemarie ForrestTaking people
  • University of Louisville HospitalLouisville, United StatesContact: Annemarie ForrestTaking people
  • Aurora St. Luke's Medical CenterMilwaukee, United StatesContact: Annemarie ForrestTaking people
  • Minneapolis Heart InstituteMinneapolis, United StatesContact: Annemarie ForrestTaking people
  • Vanderbilt University Medical CenterNashville, United StatesContact: Annemarie ForrestTaking people
  • Advocate Christ Medical CenterOak Lawn, United StatesContact: Annemarie ForrestNot yet recruiting
  • Oklahoma Heart HospitalOklahoma City, United StatesContact: Annemarie ForrestTaking people
  • University of PennsylvaniaPhiladelphia, United StatesContact: Annemarie ForrestTaking people
  • VCU Medical CenterRichmond, United StatesContact: Annemarie ForrestTaking people
  • Corewell William Beaumont University HospitalRoyal Oak, United StatesContact: Annemarie ForrestTaking people
  • UC Davis Medical CenterSacramento, United StatesContact: Annemarie ForrestTaking people
  • St. Louis VASt Louis, United StatesContact: Annemarie ForrestTaking people
  • Washington UniversitySt Louis, United StatesContact: Annemarie ForrestTaking people
  • Atrium Health Wake Forest Baptist Medical CenterWinston-Salem, United StatesContact: Annemarie ForrestTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Reprieve SystemTreatment being tested

    Participants randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.

  • Optimal Diuretic Therapy (ODT)Existing treatment, for comparison

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

    Treatment: furosemide infusion

  • RegistryNo study treatment, for comparison

    Participants will be treated per local site usual care.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II)
Plain-language title
Tests the Reprieve System for fluid removal in acute decompensated heart failureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
13 October 2026