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TerminatedNCT05318105REVERSE-HFUpdated Jun 25, 2026

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

An interventional study of Aquadex Smartflow® System and IV Loop Diuretics in Heart Failure (for Example, Fluid Overload), Heart Failure and Fluid Overload, sponsored by Nuwellis, Inc.. Terminated at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Nuwellis, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
The study was stopped early due to slow enrollment and was a business decision. This decision was not based on any efficacy or safety concerns.

From the registry’s dates

  • Primary completion was Oct 2025, 1 year ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Heart Failure (for Example, Fluid Overload)
  • Heart Failure
  • Fluid Overload

Keywords

  • Heart failure
  • Fluid overload
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 167 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Nuwellis, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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, an excess of at least 10 pounds of fluid, etc.)
  • Provide written informed consent

Exclusion criteria

Exclusion Criteria:

  • New diagnosis of heart failure
  • Acute coronary syndromes
  • Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment
  • Contraindications to systemic anticoagulation
  • Severe concomitant disease expected to prolong hospitalization or cause death in less 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 from follow-up/survival
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
167 participants (actual)

Study arms

  • Experimental
    Aquadex ultrafiltration therapy

    Device: Aquadex Smartflow® System

  • Active comparator
    IV loop diuretics

    Drug: IV Loop Diuretics

Interventions

  • DeviceAquadex Smartflow® System

    ultrafiltration

  • DrugIV Loop Diuretics

    diuretics

06

What researchers measure

Primary outcomes

  1. Time to first heart failure (HF) event

    Heart Failure (HF) event defined as any HF rehospitalization or unplanned use of IV loop diuretics, vasoactive medications or Aquadex therapy in any outpatient setting.

    Time frame: within 30 days

Secondary outcomes

  1. Win ratio analysis

    Win ratio analysis of cardiovascular (CV) mortality, HF events and quality of life

    Time frame: within 30 days

07

Study locations

15 sites
  • Banner Health
    Tucson, Arizona 85721, United States
  • MemorialCare, Long Beach Medical Center
    Long Beach, California 90806, United States
  • Sharp Memorial Hospital, San Diego Cardiac Center
    San Diego, California 92123, United States
  • BayCare Medical Group, Morton Plant
    Clearwater, Florida 33756, United States
  • University of Kentucky
    Lexington, Kentucky 40536, United States
  • Henry Ford Health
    Detroit, Michigan 48202, United States
  • Mount Sinai Morningside
    New York, New York 10025, United States
  • The Mount Sinai Hospital
    New York, New York 10029, United States
  • Northwell Health
    New York, New York 10075, United States
  • The Christ Hospital
    Cincinnati, Ohio 45219, United States
  • The Ohio State University
    Columbus, Ohio 43215, United States
  • Abington Jefferson Health
    Abington, Pennsylvania 19001, United States
  • Jackson Madison County General Hospital
    Jackson, Tennessee 38301, United States
  • Baylor Scott & White Research Institute
    Dallas, Texas 75207, United States
  • Sentara Norfolk General Heart Hospital
    Norfolk, Virginia 23507, United States
08

References and documents

Publications

  • McCallum W, Sarnak MJ. Cardiorenal Syndrome in the Hospital. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):933-945. doi: 10.2215/CJN.0000000000000064. Epub 2023 Jan 13. PubMed 36787124 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05318105
Lead sponsor
Nuwellis, Inc.
Responsible party
Sponsor
First posted
Apr 8, 2022
Start date
Jun 28, 2022
Primary completion
Oct 6, 2025
Completion
Apr 7, 2026
Last update
Jun 25, 2026

Study contacts

Sean Pinney, MD
principal investigator · Mount Sinai Morningside
Maria DeVita, MD, FASN
principal investigator · Lenox Hill Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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