Ultrafiltration Versus IV Diuretics in Worsening Heart Failure (REVERSE-HF)

Nuwellis

Status: Enrolling

Conditions: Heart Failure; Fluid Overload; Heart Failure (for Example, Fluid Overload)

Treatments: Drug: IV Loop Diuretics; Device: Aquadex Smartflow® System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05318105

CLIN07687

Details and patient eligibility

About

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.

Enrollment: 372 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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372 participants in 2 patient groups

Aquadex ultrafiltration therapy

Experimental group

Treatment:

Device: Aquadex Smartflow® System

IV loop diuretics

Active Comparator group

Treatment:

Drug: IV Loop Diuretics