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
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
Inclusion Criteria6
- 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 Criteria10
- 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
Interventions
DEVICEAquadex Smartflow® System
ultrafiltration
DRUGIV Loop Diuretics
diuretics
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT05318105
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