Reprieve Cardiovascular has announced topline results from its FASTR randomised pilot study, evaluating the Reprieve system for patients with acute decompensated heart failure (ADHF) compared to optimal diuretic therapy (ODT).
The trial met both primary efficacy and safety endpoints, results presented by James Udelson (Tufts Medical Center, Boston, USA) during a late-breaking clinical science session at the Technology and Heart Failure Therapeutics (THT) annual meeting (11–13 February, Boston, USA) have shown.
Reprieve Cardiovascular has also announced receipt of US Food and Drug Administration (FDA) approval to initiate an investigational device exemption (IDE) study—the FASTR II randomised pivotal trial—in the USA and Europe.
Results of the FASTR study have shown that in patients with ADHF and significant fluid volume overload, the Reprieve system, when compared to optimal diuretic therapy, demonstrated significantly greater sodium excretion (p<0.001), total urine output (p<0.001) and weight loss (p=0.002), and 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 were also seen with Reprieve.
“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 Udelson. “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 personalise 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 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,” said Mark Pacyna, chief executive officer of Reprieve Cardiovascular. “These results, from one of the few randomised 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 randomised 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.”
