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

Last updated: November 24, 2025
Sponsor: Reprieve Cardiovascular, Inc
Overall Status: Active - Recruiting

Phase

3

Condition

Chest Pain

Heart Failure

Hyponatremia

Treatment

Reprieve System

furosemide infusion

Clinical Study ID

NCT06898515
IDE-G210258-CLN0002
  • Ages > 22
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of HF with expected hospitalization >24 hours, with >1 new or worseningsymptom and >2 physical examination, laboratory, or invasive findings of HF, andreceiving 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 withstudy 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 IVloop diuretic >= 40 mg furosemide equivalent

Exclusion

Exclusion Criteria:

  1. Urologic issues that would predispose the participant to a high rate of urogenitaltrauma or infection with catheter placement or known inability to place a Foleycatheter.

  2. Hemodynamic instability as defined by any of the following: sustained systolic bloodpressure <90 mmHg for >15 minutes within the past 48 hours, use of IV vasopressorsor inotropes within past 48 hours, and/or current or previous mechanical circulatorysupport within the last week.

  3. Uncontrolled arrhythmias defined as sustained HR >130 beats/min for >10 minuteswithin 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 suspectedinfection with fever or elevated serum white blood cell count).

  6. Estimated glomerular filtration rate (eGFR) <25 ml/min/1.73m2 (calculated witheither MDRD or CKD-EPI) or current use of renal replacement therapy (RRT).

  7. Significant left ventricular outflow obstruction, severe uncorrected complexcongenital heart disease, known severe stenotic valvular disease, severeinfiltrative or constrictive cardiomyopathy or other diagnosis that would makeaggressive decongestion unsafe.

  8. Current or recent (< 30 days) type I myocardial infarction (e.g., acute coronarysyndrome such as NSTEMI or STEMI from plaque rupture), coronary artery bypasssurgery, or stroke. An isolated troponin elevation (e.g., from volume overload ordemand ischemia) is not a reason for exclusion.

  9. Severe electrolyte abnormalities (e.g., serum potassium <3.0 mEq/L, magnesium <1.3mEq/L or sodium <125 mEq/L). Note: These are based on baseline/screening labs.Participants whose electrolyte levels are repleted cannot be reassessed forinclusion in the trial.

  10. Other concomitant disease or condition the investigator believes will make itdifficult to follow instructions or comply with study procedures and/or follow-upvisits, including expected prolonged hospitalization for reasons other thandecongestive 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 Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Reprieve System
Phase: 3
Study Start date:
July 14, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Universitätsklinikum Gießen (UKGM)

    Giessen 2920512, 35392
    Germany

    Active - Recruiting

  • Hannover University Hospital

    Hanover 2910831, 30625
    Germany

    Active - Recruiting

  • University Hospital Heidelberg

    Heidelberg 2907911,
    Germany

    Active - Recruiting

  • Jena University Hospital

    Jena 2895044, 07747
    Germany

    Site Not Available

  • Universitaria delle Marche

    Ancona 3183089, 60121
    Italy

    Site Not Available

  • ASST Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo 3182164, 24127
    Italy

    Site Not Available

  • ASST Niguarda Great Metropolitan Hospital

    Milan 6951411, 20162
    Italy

    Site Not Available

  • Medical University of Białystok

    Bialystok 776069, 15-089
    Poland

    Active - Recruiting

  • Medical University of Lodz

    Lodz 3093133, 70445
    Poland

    Active - Recruiting

  • University Hospital Wroclaw

    Wroclaw 3081368, 45573
    Poland

    Active - Recruiting

  • Hospital de Bellvitge

    Barcelona 3128760, 08907
    Spain

    Active - Recruiting

  • Vall d'Hebron University Hospital

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Ramon y Cajal

    Madrid 3117735, 28000
    Spain

    Active - Recruiting

  • Puerta de Hierro Majadahonda University Hospital

    Madrid 3117735, 28222
    Spain

    Active - Recruiting

  • Clínico Universitario de Valencia

    Valencia 2509954, 46000
    Spain

    Active - Recruiting

  • Hospital General Valencia

    Valencia 2509954, 46000
    Spain

    Active - Recruiting

  • University of California Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • University of California Irvine

    Irvine 5359777, California 5332921 92697
    United States

    Active - Recruiting

  • Scripps Memorial Hospital

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • University of Florida

    Gainesville 4156404, Florida 4155751 32610
    United States

    Active - Recruiting

  • Piedmont Atlanta Hospital

    Atlanta 4180439, Georgia 4197000 30309
    United States

    Active - Recruiting

  • Piedmont Augusta Hospital

    Augusta 4180531, Georgia 4197000 30901
    United States

    Active - Recruiting

  • Northeast Georgia Medical Center

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Active - Recruiting

  • Advocate Christ Medical Center

    Oak Lawn 4904365, Illinois 4896861 60453
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City 4273837, Kansas 4273857 66103
    United States

    Active - Recruiting

  • University of Louisville Hospital

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • Trinity Health Ann Arbor Hospital

    Ann Arbor, Michigan 48197
    United States

    Site Not Available

  • Trinity Health Ann Arbor Hospital

    Ann Arbor 4984247, Michigan 5001836 48197
    United States

    Active - Recruiting

  • Corewell Health Butterworth Hospital

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Active - Recruiting

  • Corewell William Beaumont University Hospital

    Royal Oak 5007804, Michigan 5001836 48073
    United States

    Active - Recruiting

  • Minneapolis Heart Institute

    Minneapolis 5037649, Minnesota 5037779 55407
    United States

    Active - Recruiting

  • University of Mississippi

    Jackson 4431410, Mississippi 4436296 38677
    United States

    Active - Recruiting

  • St. Louis VA

    St. Louis, Missouri 63130
    United States

    Active - Recruiting

  • Washington University

    St. Louis, Missouri 63130
    United States

    Site Not Available

  • Harry S. Truman Veteran's Memorial Hospital

    Columbia 4381982, Missouri 4398678 65201
    United States

    Site Not Available

  • St. Louis VA

    St Louis 4407066, Missouri 4398678 63130
    United States

    Active - Recruiting

  • Washington University

    St Louis 4407066, Missouri 4398678 63130
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha 5074472, Nebraska 5073708 68198
    United States

    Active - Recruiting

  • Stony Brook University Hospital

    Stony Brook 5139865, New York 5128638 11794
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Duke University

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Moses H. Cone Memorial Hospital

    Greensboro 4469146, North Carolina 4482348 27401
    United States

    Site Not Available

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Active - Recruiting

  • Lindner Center at Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • UH Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio State University Hospital

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Lindner Center at Christ Hospital

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati 4508722, Ohio 5165418 45221
    United States

    Active - Recruiting

  • UH Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • University Hospital Cleveland

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • Ohio State University Hospital

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • Oklahoma Heart Hospital

    Oklahoma City 4544349, Oklahoma 4544379 73120
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 191904
    United States

    Active - Recruiting

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Prisma Health Greenville Memorial Hospital

    Greenville 4580543, South Carolina 4597040 29605
    United States

    Active - Recruiting

  • Baylor Scott and White

    Dallas, Texas 75246
    United States

    Site Not Available

  • Baylor Scott and White

    Dallas 4684888, Texas 4736286 75246
    United States

    Active - Recruiting

  • Baylor College of Medicine Ben Taub Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Memorial Hermann-Texas Medical Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Inova Fairfax Medical Campus

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Active - Recruiting

  • VCU Medical Center

    Richmond 4781708, Virginia 6254928 23219
    United States

    Active - Recruiting

  • UW Harborview

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

  • Aurora St. Luke's Medical Center

    Milwaukee 5263045, Wisconsin 5279468 53215
    United States

    Site Not Available

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