RecruitingNot ApplicableNCT05318105

Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload

Sponsor

Nuwellis, Inc.

Enrollment

372 participants

Start Date

Jun 28, 2022

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods of removing excess fluid from patients hospitalized with a sudden worsening of heart failure: ultrafiltration (a machine that filters the blood) versus standard IV water pills (diuretics). **You may be eligible if...** - You are 18 or older - You are not pregnant - You have been admitted to hospital with a sudden worsening of heart failure - You were already taking oral water pills, SGLT2 inhibitors, or a similar heart medication before this hospital stay - Your body is retaining significant fluid (swelling, excess weight gain of 10+ pounds) **You may NOT be eligible if...** - This is your first-ever heart failure diagnosis - You are having a heart attack - Your kidney function is severely impaired (creatinine 3.0 or higher) - You have an active infection or sepsis - You have severe aortic valve narrowing - You have active heart inflammation or constrictive pericarditis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAquadex Smartflow® System

ultrafiltration

DRUGIV Loop Diuretics

diuretics

Locations(17)

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

University of California San Francisco

San Francisco, California, United States

BayCare Medical Group, Morton Plant

Clearwater, Florida, United States

St. Joseph's Hospital

Tampa, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05318105

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