Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
Reason given: The study was stopped early due to slow enrollment and was a business decision. This decision was not based on any efficacy or safety concerns.
Key facts
- Where
- Abington, Cincinnati, Clearwater, Columbus, Dallas, Detroit, Jackson, Lexington, Long Beach, New York, Norfolk, San Diego, and Tucson, United StatesSee the 15 sites
Where in United States
- Abington Jefferson HealthAbington, United StatesNo longer taking part
- The Christ HospitalCincinnati, United StatesNo longer taking part
- BayCare Medical Group, Morton PlantClearwater, United StatesNo longer taking part
- The Ohio State UniversityColumbus, United StatesNo longer taking part
- Baylor Scott & White Research InstituteDallas, United StatesNo longer taking part
- Henry Ford HealthDetroit, United StatesNo longer taking part
- Jackson-Madison County General HospitalJackson, United StatesNo longer taking part
- University of KentuckyLexington, United StatesNo longer taking part
- MemorialCare Long Beach Medical CenterLong Beach, United StatesNo longer taking part
- Mount Sinai MorningsideNew York, United StatesNo longer taking part
- Northwell HealthNew York, United StatesNo longer taking part
- The Mount Sinai HospitalNew York, United StatesNo longer taking part
- Sentara Norfolk General Heart HospitalNorfolk, United StatesNo longer taking part
- Sharp Memorial Hospital, San Diego Cardiac CenterSan Diego, United StatesNo longer taking part
- Banner HealthTucson, United StatesNo longer taking part
Trial details
- Who runs it
- Nuwellis, Inc.
- Trial code
- NCT05318105
- Record updated
- 25 June 2026
- Original description
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.Read full original descriptionShow less
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
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.
Inclusion: 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: Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days; New diagnosis of heart failure; Acute coronary syndromes; Sepsis or ongoing systemic infection; Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival; Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment; Contraindications to systemic anticoagulation; Active myocarditis; Constrictive pericarditis or restrictive cardiomyopathy; Severe aortic stenosis.