Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Start Date
9/11/2024
Completion Date
7/1/2027
Summary
FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States. Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects.
Detailed Description
After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. After 6 weeks, subjects will have a follow up visit with a blood draw and a cardiac MRI. At this visit, subjects will be randomized 2:1 for pacing therapy or as a control (programmed into either a non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest). After 3, 6 and 9 months after randomization, subjects will return for a follow up visit. At the 9-month visit therapy modifications will be made based on initial pacing randomization assignment: pacing therapy will be terminated in the original therapy group and enabled in the control group. After an additional 3-months of follow-up, subjects will return for their final visit, therapies will be disabled in all subjects and subjects will be exited. Echocardiographic, functional, and health status endpoints will be collected and analyzed to assess therapy efficacy.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pacemaker PLR + TRT ON
Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
Conditions
Locations
NCH Heart Institute
Naples, Florida 34102
United States
Prairie Education and Research Cooperative-St. Elizabeth's
O'Fallon, Illinois 62269
United States
Prairie Education and Research Cooperative-St. John's
Springfield, Illinois 62769
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Duke University
Durham, North Carolina 27708
United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma 73120
United States
Houston Methodist Research Institute
Houston, Texas 77030
United States
The University of Vermont Medical Center
Burlington, Vermont 05401
United States