FASTR Pilot Trial Yields Positive Results for Acute Decompensated Heart Failure Treatment

Reprieve Cardiovascular Inc. is sharing encouraging results from its randomized pilot study that evaluated the Reprieve System for patients with acute decompensated heart failure (ADHF) compared with optimal diuretic therapy (ODT). The trial met both primary efficacy and safety endpoints.

The company also announced it has received U.S. Food and Drug Administration (FDA) approval to initiate an investigational device exemption (IDE) study—the FASTR II randomized pivotal trial—in the United States and Europe.

The FASTR pilot trial was a multicenter, randomized, controlled trial designed to evaluate the efficacy and safety of the Reprieve System in optimizing decongestion in ADHF patients. The trial enrolled 100 patients who were randomized 1:1 to receive treatment with the Reprieve System or optimal diuretic treatment based on best-practice dosing. Patients with ≥10 lbs (4.5 kg) of estimated volume overload were included in the trial. The primary efficacy endpoint was total urine sodium output at 24 hours post-treatment initiation, while the primary safety endpoint was the composite of acute kidney injury (AKI), severe electrolyte abnormalities, and symptomatic hypotension.

In patients with ADHF and significant fluid volume overload, the Reprieve System, when compared to ODT, demonstrated:

• Significantly greater sodium excretion (p<0.001), total urine output (p<0.001) and weight loss (p=0.002)
• No increase in the incidence of decongestion-related adverse events, including a trend towards fewer increases in serum creatine during treatment
• Reduced incidence of mortality and hospital readmissions

The results were presented by James Udelson, , during the Late-Breaking Clinical Science session at the Technology and Heart Failure Therapeutics (THT) Annual Meeting in Boston, Mass.

Related: Study Demonstrates Potential of Reprieve Cardiovascular’s Heart Failure Treatment

“Results from the FASTR trial reinforce the potential of the Reprieve System to transform ADHF treatment by delivering more effective decongestion—enabling greater sodium, fluid, and weight loss—while preserving kidney function. The trial demonstrated the Reprieve System’s ability to safely and precisely remove fluid and sodium, reducing the risks of kidney injury often seen with diuretic therapy only,” said James Udelson, M.D., principal investigator of the FASTR trial and chief of Cardiology/interim Chief Physician Executive of the CardioVascular Center at Tufts Medical Center. “Importantly, treatment with the Reprieve System was associated with an early signal of a potential reduction in death or need for heart failure readmission in the three months after discharge. If this is further proven in our upcoming larger trial, it would be very impactful and further validate its potential to completely shift the treatment paradigm in ADHF.”

Intended to personalize decongestion management and safely, quickly, and thoroughly remove excess fluid to improve patient outcomes and prevent hospital readmissions, the Reprieve System works to remove fluid and sodium through precise administration of diuretics, rapidly finding the optimal dose while replenishing the body with saline to support optimal kidney function. The Reprieve System 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 therapy is designed to integrate seamlessly into existing clinical workflows, streamline patient care, and reduce the workload for clinicians treating heart failure patients.

“The FASTR pilot trial represents an important step forward in our clinical efforts and our commitment to achieving better outcomes for ADHF patients through intelligent decongestion management,” Reprieve Cardiovascular CEO Mark Pacyna stated. “These results, from one of the few randomized pilot studies in the space, further demonstrate the potential of the Reprieve System to transform ADHF care for patients around the world. With FDA approval to start the FASTR II randomized pivotal trial, which we will initiate in the first half of this year, we’re excited to begin the next phase of Reprieve’s development. Thank you to all our clinical partners around the world for their continued support in advancing this technology.”

Acute decompensated heart failure is characterized by the sudden or gradual onset of symptoms such as difficulty breathing, leg or feet swelling, and fatigue, often requiring unplanned office visits, emergency room care, or hospitalizations, with an average stay of more than five days.¹ Nearly one in four patients are readmitted to the hospital within 30 days to address fluid volume overload, and approximately half are readmitted within six months.² Managing fluid removal in ADHF patients has been a persistent challenge, as the primary treatment of diuretics is difficult to administer precisely without real-time information on patient response. This can lead to an increased risk of kidney injury, prolonged hospital stays, inadequate fluid removal at discharge, and frequent readmissions.

Reprieve Cardiovascular is developing heart failure treatement technologies that bring intelligence to decongestion management. The company’s therapies aim to improve the lives of more than 25 million heart failure patients worldwide. Headquartered in Milford, Mass., Reprieve Cardiovascular creates solutions that address the complex challenges of heart failure management.

References
¹ Truveta Real-World Analysis: 262,673K Patient Cohort
² American Heart Association. “Heart Failure Statistics.” Circulation Research, 2021. Accessed December 3, 2024. https://www.ahajournals.org/doi/pdf/10.1161/CIRCRESAHA.121.318186.