A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Banner Health
RECRUITING
Tucson
California
MemorialCare, Long Beach Medical Center
RECRUITING
Long Beach
Sharp Memorial Hospital, San Diego Cardiac Center
RECRUITING
San Diego
University of California San Francisco
WITHDRAWN
San Francisco
Florida
BayCare Medical Group, Morton Plant
COMPLETED
Clearwater
St. Joseph's Hospital
WITHDRAWN
Tampa
Kentucky
University of Kentucky
RECRUITING
Lexington
Michigan
Henry Ford Health
RECRUITING
Detroit
New York
Mount Sinai Morningside
RECRUITING
New York
Northwell Health
RECRUITING
New York
The Mount Sinai Hospital
RECRUITING
New York
Ohio
The Christ Hospital
RECRUITING
Cincinnati
The Ohio State University
RECRUITING
Columbus
Pennsylvania
Abington Jefferson Health
RECRUITING
Abington
Tennessee
Jackson Madison County General Hospital
RECRUITING
Jackson
Texas
Baylor Scott & White Research Institute
RECRUITING
Dallas
Virginia
Sentara Norfolk General Heart Hospital
RECRUITING
Norfolk
Contact Information
Primary
Megan Cotts
megan.cotts@nuwellis.com
952-345-4217
Time Frame
Start Date: 2022-06-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 372
Treatments
Experimental: Aquadex ultrafiltration therapy
Active_comparator: IV loop diuretics
Related Therapeutic Areas
Sponsors
Leads: Nuwellis, Inc.