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Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

NCT05318105 · Nuwellis, Inc.
In plain English

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Official title
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
About this study
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 criteria
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
Enrollment target: 372 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-06-28
Estimated completion: 2026-12-31
Last updated: 2025-05-15
Interventions
Device: Aquadex Smartflow® SystemDrug: IV Loop Diuretics
Primary outcomes
  • Time to first heart failure (HF) event (within 30 days)
Sponsor
Nuwellis, Inc. · industry
Contacts & investigators
ContactMegan Cotts · contact · megan.cotts@nuwellis.com · 952-345-4217
InvestigatorSean Pinney, MD · principal_investigator, Mount Sinai Morningside
InvestigatorMaria DeVita, MD, FASN · principal_investigator, Lenox Hill Hospital
All locations (17)
Banner HealthRecruiting
Tucson, Arizona, United States
MemorialCare, Long Beach Medical CenterRecruiting
Long Beach, California, United States
Sharp Memorial Hospital, San Diego Cardiac CenterRecruiting
San Diego, California, United States
University of California San FranciscoWithdrawn
San Francisco, California, United States
BayCare Medical Group, Morton PlantCompleted
Clearwater, Florida, United States
St. Joseph's HospitalWithdrawn
Tampa, Florida, United States
University of KentuckyRecruiting
Lexington, Kentucky, United States
Henry Ford HealthRecruiting
Detroit, Michigan, United States
Mount Sinai MorningsideRecruiting
New York, New York, United States
The Mount Sinai HospitalRecruiting
New York, New York, United States
Northwell HealthRecruiting
New York, New York, United States
The Christ HospitalRecruiting
Cincinnati, Ohio, United States
The Ohio State UniversityRecruiting
Columbus, Ohio, United States
Abington Jefferson HealthRecruiting
Abington, Pennsylvania, United States
Jackson Madison County General HospitalRecruiting
Jackson, Tennessee, United States
Baylor Scott & White Research InstituteRecruiting
Dallas, Texas, United States
Sentara Norfolk General Heart HospitalRecruiting
Norfolk, Virginia, United States
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure · TrialPath