BaroPace’s First-in-Human PressurePace Trial Meets All Endpoints

BaroPace has released results from its Phase I first-in-human trial of PressurePace, a patent-pending pacemaker control algorithm to treat heart failure with preserved ejection fraction (HFpEF).
 
PressurePace met both its primary endpoints of quality of life (Minnesota Living with Heart Failure Questionnaire) and exercise tolerance (Low Level Bruce Protocol Treadmill Exercise Test) and secondary endpoints of 6-Minute Walk Time, and NYHA Score compared to placebo (standard pacing).
 
The seven-week RelieveHFpEF-II was conducted in India at four major medical centers using dual-chamber pacemakers manufactured by Shree Pacetronix Ltd. Sixteen patients were randomized to either standard pacing or using the PressurePace algorithm. Blood pressure was tracked using 24-hour monitoring at baseline, after each treatment arm, and twice daily in-home.
 
Also noted were “clinically important” changes in blood pressure related to BaroPacing. This included a drop in systolic blood pressure in hypertensive patients to the range associated with optimal mortality rates and an overall pulse pressure narrowing. These are believed to be beneficial in heart failure.
 
The average percentage of BaroPacing for the treatment arms’ duration was 12%. The company said this suggests inducing persistent heart rate elevation in HFpEF patients with possible coexistent cardiovascular disease isn’t necessary. No adverse events were reported from PressurePace therapy.
 
“We are deeply appreciative for the participation of the heart failure patients, medical centers, and clinical investigators in India,” said Michael Burnam, MD, FACP, FACC, CEO and founder of BaroPace. “A safe, effective treatment of HFpEF is a critical global unmet need. HFpEF is the most common form of heart failure worldwide and in most cases the result of treatment resistant hypertension. Although pharmacologic therapy may offer promise for the treatment of HFpEF, no device therapy is now available.”
 
A U.S. pivotal trial of PressurePace in HFpEF, RelieveHFpEF-III, is also in the planning stage. The trial will include pilot first-in-human feasibility studies of PressurePace in resistant hypertension. It will assess the CentrusDx SmartBand 1 medical-grade, wrist-worn, cuffless blood pressure monitor as a method of blood pressure input to PressurePace.
 
“PressurePace is a safe, very well tolerated, easy to implement personalized therapy for HFpEF, a real-time, closed-loop system that is active only when required,” said Dr. Burnam. “The results of RelieveHFpEF-II are consistent with published retrospective and short-term prospective clinical studies. We are excited to begin planning RelieveHFpEF-III, the US multi-center pivotal trial of PressurePace in HFpEF patients that will study the safety and effectiveness of PressurePace in a larger number of patients over a longer period of time and to begin evaluation of PressurePace in resistant hypertension and its integration with a new cuffless blood pressure measurement device.”