Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
REVERSE-HF
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
1 other identifier
interventional
372
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedStudy Start
First participant enrolled
June 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 15, 2025
May 1, 2025
4.3 years
March 10, 2022
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first heart failure (HF) event
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.
within 30 days
Secondary Outcomes (1)
Win ratio analysis
within 30 days
Study Arms (2)
Aquadex ultrafiltration therapy
EXPERIMENTALIV loop diuretics
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nuwellis, Inc.lead
Study Sites (17)
Banner Health
Tucson, Arizona, 85721, United States
MemorialCare, Long Beach Medical Center
Long Beach, California, 90806, United States
Sharp Memorial Hospital, San Diego Cardiac Center
San Diego, California, 92123, United States
University of California San Francisco
San Francisco, California, 94143, United States
BayCare Medical Group, Morton Plant
Clearwater, Florida, 33756, United States
St. Joseph's Hospital
Tampa, Florida, 33614, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Henry Ford Health
Detroit, Michigan, 48202, United States
Mount Sinai Morningside
New York, New York, 10025, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
Northwell Health
New York, New York, 10075, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
The Ohio State University
Columbus, Ohio, 43215, United States
Abington Jefferson Health
Abington, Pennsylvania, 19001, United States
Jackson Madison County General Hospital
Jackson, Tennessee, 38301, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75207, United States
Sentara Norfolk General Heart Hospital
Norfolk, Virginia, 23507, United States
Related Publications (1)
McCallum W, Sarnak MJ. Cardiorenal Syndrome in the Hospital. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):933-945. doi: 10.2215/CJN.0000000000000064. Epub 2023 Jan 13.
PMID: 36787124DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Pinney, MD
Mount Sinai Morningside
- PRINCIPAL INVESTIGATOR
Maria DeVita, MD, FASN
Lenox Hill Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2022
First Posted
April 8, 2022
Study Start
June 28, 2022
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share