Nuwellis Announces the Activation of New Sites for Its Pivotal REVERSE-HF Trial
"We have significant experience providing ultrafiltration therapy to patients with acute decompensated heart failure and our recent 10-year retrospective study showed that it compares favorably in reducing heart failure rehospitalizations, renal function response, and weight and fluid volume loss1,” said Dr.
Heart failure can disrupt normal kidney function 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
“Fluid overload is a significant contributor to morbidity and mortality in heart failure patients. In addition, the frequent hospital readmissions to treat these patients result in a tremendous burden to our healthcare system,” said Dr.
REVERSE-HF is a multicenter, open-label, randomized controlled trial that is being conducted across
“The current standard of care for treating fluid-overloaded heart failure patients has led to mixed outcomes due to a significant number of them not responding to traditional diuretics,” said Dr.
“We are excited about the activation of
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 uses a statistical method that increases precision in demonstrating significant differences in clinical outcomes between treatment arms. This statistical method, called the Finkelstein-Schoenfeld method of Win-Ratios, has also been used recently to re-evaluate data obtained during the AVOID–HF (Aquapheresis Versus Intravenous Diuretics and Hospitalization for Heart Failure) 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 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 will be presented as a late-breaking abstract at the Heart Failure Society of America Annual
In addition to Jefferson Abington, USCF, and BayCare Morton Plant, Nuwellis is currently partnering with other clinical institutions that will soon be enrolling patients for the REVERSE-HF study as well. The Company anticipates at least 12 clinical institutions will participate in the study.
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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1. Watson R, et al. J Card Fail. 2020; 26(10): S56.
2. Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19)2428-2445
George Montague, CFA Chief Financial Officer, Nuwellis, Inc. firstname.lastname@example.org Leigh SalvoGilmartin Group LLC email@example.com MEDIA: Sarah Lundberg Health+Commerce firstname.lastname@example.org
Source: Nuwellis, Inc.