Nuwellis Announces the Submission of the AVOID-HF Clinical Analysis as a Late Breaking Clinical Trial at HFSA
The AVOID-HF (Aquapheresis Versus Intravenous Diuretics and Hospitalization for Heart Failure) prospective, multicenter, randomized controlled trial tested the hypothesis that patients hospitalized for heart failure (HF) 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. The study was trending favorably when the study sponsor terminated it before reaching full enrollment for reasons unrelated to patient safety or clinical futility. At the time, analysis of the AVOID-HF trial data was inconclusive due to the lower-than-planned sample size. However, newer statistical methods like the Finkelstein-Schoenfeld method of hierarchical Win Ratios increase statistical precision to evaluate the clinical benefit and demonstrate significance between treatment arms with the added benefit of requiring a smaller study sample size.
“The Finkelstein-Schoenfeld method of hierarchical Win Ratios provides a critical framework for evaluating the data obtained from the 221 patients enrolled in the AVOID-HF study,” said Dr.
Heart failure can disrupt normal kidney function and lower the 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
“The Win-Ratios analysis of the AVOID-HF clinical study will provide additional evidence to support the use of ultrafiltration to treat fluid-overloaded heart failure patients,” said
In addition to the AVOID-HF Win-Ratios analysis and submission, Nuwellis recently announced the first patient enrolled in its REVERSE-HF clinical study evaluating the clinical benefit and economic value of its Aquadex® ultrafiltration therapy in comparison to intravenous (IV) diuretics for the treatment of fluid overload in patients with worsening heart failure. Nuwellis also submitted information on REVERSE-HF to HFSA’s Clinical Trials Central, as a currently enrolling heart failure randomized controlled trial.
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 Costanzo MR et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445
2 Andrew H Lin et al. Mil Med. 2017 Sep.
George Montague, CFA Chief Financial Officer, Nuwellis, Inc.firstname.lastname@example.org Matt Bacso, CFA Gilmartin Group LLCMatt.Bacso@gilmartinir.com MEDIA: Sarah LundbergHealth+Commerce email@example.com
Source: Nuwellis, Inc.