Heart Failure (for Example, Fluid Overload), Heart Failure, Fluid Overload
Conditions
Keywords
Heart failure, Fluid overload
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.
Interventions
DEVICEAquadex Smartflow® System
ultrafiltration
diuretics
Sponsors
Nuwellis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first heart failure (HF) event | within 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Win ratio analysis | within 30 days | Win ratio analysis of cardiovascular (CV) mortality, HF events and quality of life |
Countries
United States
Contacts
Primary ContactMegan Cotts
Outcome results
None listed