Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

Stopped early · Not applicable

Conditions studied: Heart Failure (for Example, Fluid Overload), Heart Failure, Fluid Overload

In brief

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.

Key facts

Study ID

NCT05318105

Run by

Nuwellis, Inc.

People needed

167

Starts

2022-06-28

Expected to finish

2026-04-07

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner Health — Tucson, Arizona, United States
• MemorialCare, Long Beach Medical Center — Long Beach, California, United States
• Sharp Memorial Hospital, San Diego Cardiac Center — San Diego, California, United States
• BayCare Medical Group, Morton Plant — Clearwater, Florida, United States
• University of Kentucky — Lexington, Kentucky, United States
• Henry Ford Health — Detroit, Michigan, United States
• Mount Sinai Morningside — New York, New York, United States
• The Mount Sinai Hospital — New York, New York, United States
• Northwell Health — New York, New York, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Abington Jefferson Health — Abington, Pennsylvania, United States
• Jackson Madison County General Hospital — Jackson, Tennessee, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States
• Sentara Norfolk General Heart Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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