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

Last updated: July 21, 2025
Sponsor: Reprieve Cardiovascular, Inc
Overall Status: Active - Recruiting

Phase

3

Condition

Chest Pain

Heart Failure

Congestive Heart Failure

Treatment

furosemide infusion

Reprieve System

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: furosemide infusion
Phase: 3
Study Start date:
July 14, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • University of California Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • Trinity Health Ann Arbor Hospital

    Ann Arbor, Michigan 48197
    United States

    Active - Recruiting

  • St. Louis VA

    St. Louis, Missouri 63130
    United States

    Active - Recruiting

  • Washington University

    St. Louis, Missouri 63130
    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

    Active - Recruiting

  • Lindner Center at Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Ohio State University Hospital

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Baylor Scott and White

    Dallas, Texas 75246
    United States

    Site Not Available

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