A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
Nuwellis, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 re…
Interventions
- DeviceAquadex Smartflow® System
ultrafiltration
- DrugIV Loop Diuretics
diuretics
Locations (17)
- Banner HealthTucson, Arizona
- MemorialCare, Long Beach Medical CenterLong Beach, California
- Sharp Memorial Hospital, San Diego Cardiac CenterSan Diego, California
- University of California San FranciscoSan Francisco, California
- BayCare Medical Group, Morton PlantClearwater, Florida
- St. Joseph's HospitalTampa, Florida