Nuwellis Announces First Patient Enrolled in its Pivotal Trial REVERSE-HF
"Heart failure is among the leading causes of hospitalizations due to the accumulation of fluid requiring decongestion in the hospital setting. Unfortunately, approximately 1 in 4 patients are readmitted to the hospital within 30 days of discharge," said
Heart failure can disrupt normal kidney functions and lower their ability to remove sodium from the body, resulting in excessive water retention that can ultimately lead to fluid overload. Over 1 million heart failure hospitalizations occur annually in
REVERSE-HF is a multicenter, open-label, randomized controlled trial that will be conducted across
“The first patient enrolled in REVERSE-HF marks an exciting milestone in this study,” said
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 IV loop diuretics. The study will assess safety parameters, including, but not limited to, cardiovascular and renal-related adverse events of special interest.
REVERSE-HF will use a newer statistical method that increases precision in demonstrating significance between the ultrafiltration and IV diuretic treatment arms of the study. This statistical method, called Finkelstein-Schoenfeld method of Win-Ratios, has also been used recently to re-evaluate data obtained during the AVOID–HF prospective, multicenter, randomized controlled trial, which was the first to propose that patients should be treated with adjustable ultrafiltration when compared to those receiving adjustable loop diuretics. The AVOID-HF (Aquapheresis Versus Intravenous Diuretics and Hospitalization for Heart Failure) trial tested the hypothesis that patients hospitalized for heart failure and treated with ultrafiltration would have a longer time to their first heart failure event within 90 days after hospital discharge compared to those receiving IV loop diuretics. AVOID-HF was trending favorably when it was terminated before reaching full enrollment for reasons unrelated to patient safety or clinical futility. The Win-Ratio analysis of AVOID-HF, which showed superiority of ultrafiltration over diuretics, is expected to be published in a peer reviewed journal later this year.
In addition to
About the Aquadex SmartFlow® System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and predictable method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
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Source: Nuwellis, Inc.