Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

Last updated: May 12, 2025
Sponsor: Nuwellis, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Aquadex Smartflow® System

IV Loop Diuretics

Clinical Study ID

NCT05318105
CLIN07687
  • Ages > 18
  • All Genders

Study Summary

The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older

  • Man, or non-pregnant woman

  • Admitted to the hospital with a diagnosis of acute decompensated heart failure

  • On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2)Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) prior to admission

  • Fluid overload manifested by at least three clinical indications (e.g., edema, anexcess of at least 10 pounds of fluid, etc.)

  • Provide written informed consent

Exclusion

Exclusion Criteria:

  • New diagnosis of heart failure

  • Acute coronary syndromes

  • Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time ofenrollment

  • Contraindications to systemic anticoagulation

  • Severe concomitant disease expected to prolong hospitalization or cause death inless than 90 days

  • Sepsis or ongoing systemic infection

  • Active myocarditis

  • Constrictive pericarditis or restrictive cardiomyopathy

  • Severe aortic stenosis

  • Any condition in the opinion of the investigator that would prevent the patient fromfollow-up/survival

Study Design

Total Participants: 372
Treatment Group(s): 2
Primary Treatment: Aquadex Smartflow® System
Phase:
Study Start date:
June 28, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Banner Health

    Tucson, Arizona 85721
    United States

    Active - Recruiting

  • MemorialCare, Long Beach Medical Center

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Sharp Memorial Hospital, San Diego Cardiac Center

    San Diego, California 92123
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • BayCare Medical Group, Morton Plant

    Clearwater, Florida 33756
    United States

    Completed

  • St. Joseph's Hospital

    Tampa, Florida 33614
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Mount Sinai Morningside

    New York, New York 10025
    United States

    Active - Recruiting

  • Northwell Health

    New York, New York 10075
    United States

    Active - Recruiting

  • The Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Abington Jefferson Health

    Abington, Pennsylvania 19001
    United States

    Active - Recruiting

  • Jackson Madison County General Hospital

    Jackson, Tennessee 38301
    United States

    Active - Recruiting

  • Baylor Scott & White Research Institute

    Dallas, Texas 75207
    United States

    Active - Recruiting

  • Sentara Norfolk General Heart Hospital

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.