Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nuwellis, Inc.
• Treatments: Diuretics; Sodium Potassium Chloride Symporter Inhibitors

Criteria

Inclusion Criteria:

• 18 years or older

• Man, or non-pregnant woman

• Admitted to the hospital with a primary diagnosis of acute decompensated heart failure

• On regularly prescribed oral loop diuretics 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