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Life sciences · Interventional Study
ClinicalTrials.gov · October 28, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT05839730). This is a study registration, not published results. Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 105 participants (ESTIMATED). Conditions: Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy. Interventions: DEVICE: Pacemaker PLR + TRT ON; DEVICE: Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.. Primary outcome measures: 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. , 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. , 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. , Through study completion, projected for three years until last subject last 12-month visit.. Brief 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.