BaroPace Announces RelieveHFpEF-II, Its Phase I First-in-Human Trial of PressurePace™, Its Patent-Pending Pacemaker Control Algorithm for the Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF), Met All Primary and Secondary Endpoints
June 18 2024 - 8:30AM
Business Wire
BaroPace Inc. announces its Phase I first-in-human trial of
PressurePaceTM, its patent-pending pacemaker control algorithm for
the treatment of heart failure with preserved ejection fraction
(HFpEF), 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 PressurePaceTM system wirelessly
links a pacemaker, a blood pressure cuff, and the PressurePaceTM
algorithm, a real-time, closed-loop system of therapy for patients
with HFpEF.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240615206017/en/
RelieveHFpEF-II was a 7-week trial conducted in India at four
major medical centers using dual chamber pacemakers manufactured by
Shree Pacetronix Ltd, India. After baseline assessments, sixteen
patients were randomized to one of two three-week treatment arms:
standard pacing, or BaroPacing utilizing the PressurePaceTM
algorithm. Blood pressure was measured using 24-hour blood pressure
monitoring at baseline, after each treatment arm, and twice daily
in-home using a blood pressure cuff. Clinically important changes
in blood pressure associated with BaroPacing were also noted,
including a drop in systolic blood pressure in hypertensive
patients to the range associated with optimal mortality rates, and
an overall narrowing of pulse pressure, thought to be beneficial in
heart failure. The average percentage of BaroPacing for the
treatment arms’ duration was 12% suggesting that inducing
persistent elevation of heart rate in HFpEF patients who may also
have coexistant cardiovascular disease is unnecessary. No adverse
events were reported from PressurePaceTM therapy.
The results of the trial were presented at HRS 2024 in Boston.
Two peer-reviewed manuscripts are in preparation. A US multicenter
pivotal trial of PressurePaceTM in HFpEF, RelieveHFpEF-III, is in
the planning stage. The RelieveHFpEF-III trial program will also
include pilot first-in-human feasibility studies of PressurePaceTM
in resistant hypertension, and will evaluate a state of the art
medical grade wrist-worn cuffless blood pressure measuring device
(CentrusDx SmartBand 1, from Centrus Diagnostics Inc.) as a method
of blood pressure input to PressurePaceTM.
“We are deeply appreciative for the participation of the heart
failure patients, medical centers, and clinical investigators in
India,” Michael Burnam, MD, FACP, FACC, CEO and founder of BaroPace
commented. “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.
PressurePaceTM 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. The results of RelieveHFpEF-II
are consistent with published retrospective (1) and short-term
prospective clinical studies (2). We are excited to begin planning
RelieveHFpEF-III, the US multi-center pivotal trial of
PressurePaceTM in HFpEF patients that will study the safety and
effectiveness of PressurePaceTM in a larger number of patients over
a longer period of time and to begin evaluation of PressurePaceTM
in resistant hypertension and its integration with a new cuffless
blood pressure measurement device.”
PressurePaceTM, BaroPacing, and the CentrusDx SmartBand 1 are
not approved for sale in any market and are being evaluated in
clinical studies.
(1) Nguyen, et al., 2024, Innovations in CRM
(2) Burnam et al., 2024, ESC Heart Failure
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240615206017/en/
Michael Burnam contact@baropace.com