Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

Launched by NUWELLIS, INC. · Mar 31, 2022

Keywords

ClinConnect Summary

The REVERSE-HF study is looking at two different treatments for patients with worsening heart failure, a condition where the heart struggles to pump blood effectively, often leading to fluid buildup in the body. This trial is comparing a method called ultrafiltration, which uses a special device to remove excess fluid, to traditional intravenous (IV) diuretics, which are medications given through a vein to help the body get rid of extra fluid. The goal is to see which method provides better outcomes for patients dealing with this issue.

To join the study, participants must be 18 years or older and currently hospitalized with worsening heart failure. They should have been taking certain heart medications before coming to the hospital and show clear signs of fluid overload, such as swelling in the legs or rapid weight gain. If eligible, participants will receive either ultrafiltration or IV diuretics and will be closely monitored throughout the trial. This research aims to improve treatment options for heart failure patients and may help doctors provide better care in the future.

Gender

ALL

Eligibility criteria

• 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