Nuwellis Initiates REVERSE-HF Study to Evaluate Ultrafiltration for Heart Failure Patients with Fluid Overload

February 21, 2022 – Nuwellis, Inc. has announced the company will evaluate the clinical outcomes and economic value of its Aquadex therapy in comparison to intravenous diuretics for the treatment of fluid overload in patients with worsening heart failure through its randomized controlled trial, Ultrafiltration Versus IV Diuretics in Worsening Heart Failure, the REVERSE-HF Study.

REVERSE-HF is a multicenter, open-label, randomized controlled trial with an adaptive design that will be conducted across the United States. The study will be led by Sean Pinney, M.D., Professor of Medicine and Co-Director of the Heart and Vascular Center at The University of Chicago Medicine, and Maria V. DeVita, M.D., Professor of Medicine at Hofstra School of Medicine/Northwell and Chief of the Division of Nephrology at Lenox Hill Hospital. Enrollment in the trial will begin this year.

“Traditional diuretics can result in mixed outcomes, and people with heart failure who are experiencing fluid overload don’t always respond to them,” said Pinney. “We’re excited to further evaluate how ultrafiltration with Aquadex may optimally treat these patients.”

The primary effectiveness endpoint of REVERSE-HF will evaluate mortality and heart failure events within 30 days and 90 days as a comparison between Aquadex therapy and intravenous (IV) loop diuretics. The study will assess safety parameters, including but not limited to cardiovascular and renal related adverse events of special interest.

Heart failure can disrupt normal kidney functions and lower their ability to remove sodium from the body, which can cause excessive water retention resulting in fluid overload. Over 1 million heart failure hospitalizations occur annually in the United States, and fluid overload is the predominant cause. Furthermore, nearly one quarter of heart failure patients will be readmitted to the hospital within 30 days of their initial discharge, and half will be readmitted within 6 months.¹

“Heart failure patients suffering from fluid overload are frequently readmitted to the hospital, resulting in a tremendous burden to both patients and our healthcare systems,” said DeVita. “We’re looking forward to learning more about how ultrafiltration can improve patient quality of life and prevent these readmissions.”

For more information: www.nuwellis.com/

Reference: 

[1] Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445.