Reprieve Cardiovascular has announced the publication of results from its FASTR randomised pilot study in JACC: Heart Failure. The published data support the ongoing FASTR II randomised pivotal trial, currently enrolling patients in the USA and Europe.
Reprieve Therapy works to remove fluid and sodium through administration of diuretics, finding the optimal dose while replenishing the body with saline to support optimal kidney function, using real-time physiological monitoring with recommendations to escalate or end therapy.
The FASTR pilot trial reported that Reprieve Therapy produced faster decongestion than optimal diuretic therapy (ODT), without an increased risk of safety events or worsening kidney function. In patients with acute decompensated heart failure (ADHF) and significant fluid volume overload, Reprieve Therapy, when compared to ODT, demonstrated: 24-hour total natriuresis was significantly greater (p<0.001); significantly greater rate of weight loss (p=0.002), net fluid loss (p=0.03), and net natriuresis (p< 0.001), and; no differences in the primary safety endpoint (p=0.42) or change in serum creatine levels between the groups (p=0.07).
“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,” said James E Udelson (Tufts Medical Center, Boston, USA) and principal investigator of the FASTR trial. “These findings support a more individualised, 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 peer-reviewed publication of these findings provides important validation of Reprieve Therapy’s potential to address longstanding challenges in decongestion management and supports the ongoing FASTR II pivotal trial, which is designed to further evaluate these results, the company says in a press release.
“This moment reflects meaningful progress toward rethinking how acute heart failure is managed,” said Mark Pacyna, CEO of Reprieve Cardiovascular. “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, randomised, US pilot study set the foundation for the FASTR II pivotal trial, where enrolment is expected to be completed later this year. These clinical milestones advance Reprieve’s path toward redefining the standard of care in ADHF.”
