Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05318105

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

Led by Nuwellis, Inc. · Updated on 2025-05-15

372

Participants Needed

17

Research Sites

235 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • New diagnosis of heart failure
  • Acute coronary syndromes
  • Creatinine 64 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Banner Health

Tucson, Arizona, United States, 85721

Actively Recruiting

2

MemorialCare, Long Beach Medical Center

Long Beach, California, United States, 90806

Actively Recruiting

3

Sharp Memorial Hospital, San Diego Cardiac Center

San Diego, California, United States, 92123

Actively Recruiting

4

University of California San Francisco

San Francisco, California, United States, 94143

Withdrawn

5

BayCare Medical Group, Morton Plant

Clearwater, Florida, United States, 33756

Completed

6

St. Joseph's Hospital

Tampa, Florida, United States, 33614

Withdrawn

7

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

8

Henry Ford Health

Detroit, Michigan, United States, 48202

Actively Recruiting

9

Mount Sinai Morningside

New York, New York, United States, 10025

Actively Recruiting

10

The Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

11

Northwell Health

New York, New York, United States, 10075

Actively Recruiting

12

The Christ Hospital

Cincinnati, Ohio, United States, 45219

Actively Recruiting

13

The Ohio State University

Columbus, Ohio, United States, 43215

Actively Recruiting

14

Abington Jefferson Health

Abington, Pennsylvania, United States, 19001

Actively Recruiting

15

Jackson Madison County General Hospital

Jackson, Tennessee, United States, 38301

Actively Recruiting

16

Baylor Scott & White Research Institute

Dallas, Texas, United States, 75207

Actively Recruiting

17

Sentara Norfolk General Heart Hospital

Norfolk, Virginia, United States, 23507

Actively Recruiting

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Research Team

M

Megan Cotts

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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