MILFORD, Mass. — Reprieve Cardiovascular Inc. said results from a randomized pilot study of its acute heart failure treatment have been published in JACC: Heart Failure, providing support for the company’s ongoing pivotal trial in the U.S. and Europe.
The Milford-based development-stage company is focused on treatment for acute decompensated heart failure, a condition in which patients experience worsening symptoms often linked to fluid overload.
The FASTR pilot trial found that Reprieve Therapy produced faster decongestion than optimal diuretic therapy, without an increased risk of safety events or worsening kidney function, according to the company. Reprieve said patients treated with its therapy had significantly greater 24-hour total natriuresis, a greater rate of weight loss, higher net fluid loss and greater net natriuresis compared with optimal diuretic therapy.
“In FASTR, patients achieved similar levels of decongestion in roughly half the time compared to usual care, with significantly improved diuretic efficiency and no signal of kidney injury,” James E. Udelson, M.D., chief of the Division of Cardiology at Tufts Medical Center and principal investigator of the FASTR trial, said in a statement. “These findings support a more individualized, physiologically guided strategy that has the potential to improve the effectiveness and consistency of care while maintaining renal safety. I’d like to thank the investigators and study teams for their dedication to this important work.”
The study also found no differences in the primary safety endpoint or changes in serum creatinine levels between the treatment groups, the company said.
Reprieve said the peer-reviewed publication provides validation for its approach to decongestion management and supports the FASTR II randomized pivotal trial, which is currently enrolling patients.
“This moment reflects meaningful progress toward rethinking how acute heart failure is managed,” Mark Pacyna, chief executive officer of Reprieve Cardiovascular, said in a statement. “For decades, clinicians have faced a fundamental trade-off between achieving effective decongestion and protecting kidney function. The FASTR results show that a different approach may be possible. Investing in a large, randomized, US pilot study set the foundation for the FASTR II pivotal trial, where enrollment is expected to be completed later this year. These clinical milestones advance Reprieve’s path toward redefining the standard of care in ADHF.”
The company said enrollment in FASTR II is expected to be completed later this year.
