FASTR Pilot Results Published In JACC: Heart Failure

Key Takeaways

• A faster decongestion signal was reported with Reprieve Therapy than with optimal diuretic therapy.
• No difference was reported in the primary safety endpoint or in change in serum creatinine between the treatment groups.
• FASTR II is ongoing in the United States and Europe and is intended to support a future FDA premarket approval submission.

Reprieve Cardiovascular announced publication of the FASTR pilot study in JACC: Heart Failure, reporting significantly greater 24-hour total natriuresis with Reprieve Therapy than optimal diuretic therapy (P < 0.001). In the pilot study, Reprieve Therapy was also associated with faster decongestion, with no reported difference in the primary safety endpoint or in change in serum creatinine between groups. The comparison focused on two decongestion strategies during the first 24 hours after treatment initiation.

FASTR was a multicenter randomized controlled pilot study in patients with acute decompensated heart failure and marked congestion at presentation. The trial enrolled 100 patients, and 96 were randomized 1:1 to Reprieve Therapy or optimal diuretic therapy. Eligible patients had at least 10 lb, or 4.5 kg, of estimated volume overload at baseline. The primary efficacy endpoint was total urine sodium output at 24 hours after treatment initiation, and the comparator reflected best-practice dosing. The comparison focused on measured sodium and fluid removal during the first 24 hours of treatment.

The company said Reprieve Therapy uses precise administration of diuretics, saline replenishment, and real-time physiological monitoring to guide fluid removal during active treatment. It also said the system provides recommendations on whether therapy should be escalated or brought to a close during treatment. Beyond the primary efficacy endpoint, the pilot data showed greater weight loss with Reprieve Therapy than with optimal diuretic therapy (P = 0.002). Net fluid loss (P = 0.03) and net natriuresis (P < 0.001) were also greater with the device-guided approach. These differences were reported across several related measures of early decongestion.

The primary safety endpoint combined acute kidney injury, severe electrolyte abnormalities, symptomatic hypotension, and hypertensive emergencies. Researchers reported no difference in that composite endpoint between groups (P = 0.42) and no difference in change in serum creatinine (P = 0.07). It said FASTR II is a randomized pivotal trial enrolling patients in the United States and Europe across clinical sites, with enrollment expected to be completed later this year. The company said the trial is intended to support a future U.S. Food and Drug Administration premarket approval submission. The Reprieve System remains investigational, is limited by federal law to investigational use only, and is not available for sale in the United States.