FASTR Trial Assessing the Safety and Efficacy of the Reprieve System Compared to Optimal Diuretic Therapy
Milford, MA — October 7, 2024 — Reprieve Cardiovascular, Inc., a development-stage company pioneering an intelligent automated diuretic and fluid management approach for acute decompensated heart failure (ADHF) treatment, today announced the completion of enrollment in the "Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (“FASTR”) trial.
The FASTR trial aims to compare the effectiveness of decongestive therapy administered by the Reprieve System with Optimal Diuretic Therapy (ODT) in patients diagnosed with ADHF. The primary objective of the study is to determine whether the Reprieve System can more efficiently decongest ADHF patients compared to standard-of-care therapy.
"For decades, managing fluid removal in patients with ADHF has presented a significant challenge, with many failed trials of new drugs or devices," said James Udelson, M.D., Chief of Cardiology at Tufts Medical Center in Boston and principal investigator of the FASTR trial. "Diuretics, which have been the only widely used therapeutic option, are difficult to administer precisely without real-time information on patient response, making it challenging to balance rapid fluid removal with the risk of kidney injury, and thus are rarely used optimally. In addition, these patients are often faced with lengthy hospital stays, incomplete decongestion at discharge and frequent readmissions due to fluid volume overload. The Reprieve System is a promising heart failure management solution that can be easily implemented into existing clinical workflows, while also elevating the current level of care. As a result, this may help ease the workload burden for clinicians treating heart failure patients."
Intended to personalize decongestion management and safely, quickly, and completely remove excess fluid to improve patient outcomes and prevent hospital readmissions, the Reprieve System works with the kidneys to remove fluid through precise administration of diuretics, rapidly finding the optimal dose while ensuring they receive an adequate amount of sodium to support optimal kidney function. The Reprieve System uniquely combines real-time physiological monitoring with automated recommendations to escalate or end therapy, enabling physicians to tailor treatment to each patient’s specific needs during therapy. This approach aims to safely accelerate fluid removal and improve patient outcomes while reducing the likelihood of kidney injury and hospital readmissions for patients with ADHF.
The trial enrolled a total of 100 patients who were randomized into two groups. The experimental group received personalized treatment using the Reprieve System. The active comparator group received Optimal Diuretic Therapy.
The primary efficacy endpoint of the study is the total urine sodium output at 24 hours post-treatment initiation. The primary safety endpoint includes clinically significant acute kidney injury, symptomatic hypotension or hypertensive emergency. Secondary outcomes will assess the net fluid removal during treatment, heart failure rehospitalization and the total time on loop diuretics.
"Completing enrollment in the FASTR trial marks a significant milestone for Reprieve as we advance our mission to improve the lives of patients living with heart failure," said Mark Pacyna, Chief Executive Officer of Reprieve Cardiovascular. "We designed this study as a large, randomized pilot, which is uncommon in this space, to rigorously assess the safety and effectiveness of the Reprieve System in US patients before embarking on a global pivotal trial. We would like to thank and recognize all the clinical research teams for their partnership in the FASTR trial. We look forward to advancing our clinical program, with the initiation of a pivotal study before the end of the year and a data readout from the FASTR trial in the first half of 2025.”
About Heart Failure
Heart failure is a significant and growing public health issue, affecting over 6.7 million Americans today. Acute decompensated heart failure, characterized by a rapid onset of fluid volume overload, leads to over one million hospital admissions annually in the U.S. alone. Despite current treatment options, nearly 25% of patients are readmitted within 30 days, highlighting the need for more effective management strategies.
About Reprieve Cardiovascular, Inc.
Reprieve Cardiovascular is committed to advancing the treatment of heart failure by developing groundbreaking technologies that bring intelligence to decongestion management. The company's innovative therapies aim to improve the lives of over 25 million heart failure patients worldwide. Headquartered in Milford, Massachusetts, Reprieve Cardiovascular is dedicated to pioneering solutions that address the complex challenges of heart failure management.
Contact:
Julia Fuller
Ford Hutman Media
858-692-2001
julia@fordhutmanmedia.com