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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
RAMware modified implantable pulse generator (IPG) with personalized lower rate (PLR) and tachycardia remodeling therapy (TRT) ON
RAMware modified implantable pulse generator (IPG)
NCH Heart Institute
Naples, Florida, United States
Prairie Education and Research Cooperative-St. Elizabeth's
O'Fallon, Illinois, United States
Prairie Education and Research Cooperative-St. John's
Springfield, Illinois, United States
University of Kansas Medical Center
characterize the effect of TRT + PLR on cardiac structure. LV mass, LVEDV, LVESV, and wall thickness which will be collected at baseline, 3-month, 6-month, 9-month, and 12-month visits.
Time frame: Through study completion, projected for three years until last subject last 12-month visit.
Characterize the effect of pacing therapies on health status, defined as change in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 3, 6, and 9 months.
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated patient-oriented measure of the adverse effects of heart failure on a patient's life. Each of the 21 questions are scored on a 6-point Likert Scale (0 to 5), the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life.
Time frame: Through study completion, projected for three years until last subject last 12-month visit.
Characterize the durability of cardiac remodeling changes and assess the safety and tolerability of TRT + PLR.
Time frame: Through study completion, projected for three years until last subject last 12-month visit.
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Kansas City, Kansas, United States
Duke University
Durham, North Carolina, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Houston Methodist Research Institute
Houston, Texas, United States
The University of Vermont Medical Center
Burlington, Vermont, United States