Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

Not Applicable

Recruiting

• Conditions: Heart Failure (for Example, Fluid Overload); Heart Failure; Fluid Overload
• Interventions: Device: Aquadex Smartflow® System; Drug: IV Loop Diuretics

• Registration Number: NCT05318105
• Lead Sponsor: Nuwellis, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-08
• Study Start: 2022-06-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 372

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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aquadex ultrafiltration therapy	Aquadex Smartflow® System	-
IV loop diuretics	IV Loop Diuretics	-

Primary Outcome Measures

Name	Time	Method
Time to first heart failure (HF) event	within 30 days	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.

Secondary Outcome Measures

Name	Time	Method
Win ratio analysis	within 30 days	Win ratio analysis of cardiovascular (CV) mortality, HF events and quality of life

Trial Locations

Locations (17)

Sharp Memorial Hospital, San Diego Cardiac Center; 🇺🇸 San Diego, California, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Banner Health; 🇺🇸 Tucson, Arizona, United States

St. Joseph's Hospital; 🇺🇸 Tampa, Florida, United States

MemorialCare, Long Beach Medical Center; 🇺🇸 Long Beach, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

BayCare Medical Group, Morton Plant; 🇺🇸 Clearwater, Florida, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Mount Sinai Morningside; 🇺🇸 New York, New York, United States

Henry Ford Health; 🇺🇸 Detroit, Michigan, United States

Northwell Health; 🇺🇸 New York, New York, United States

The Mount Sinai Hospital; 🇺🇸 New York, New York, 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

The Ohio State University; 🇺🇸 Columbus, Ohio, United States