Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronic Cardiac Rhythm and Heart Failure
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of Heart Failure, Left Ventricular Ejection Fraction (LVEF) ≥ 55% (this and other measurements must be made within the last year).
New York Heart Association (NYHA) Functional Class I-III
Stable on guideline-directed medical therapy (GDMT) heart failure medications as determined by the investigator, for at least 1 month, with the exception of loop diuretic therapy. GDMT should be in accordance with current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines and include consideration of Sodium/glucose cotransporter-2 inhibitors (SGLT2i) therapy.
V End Diastolic Volume indexed to body surface area (BSA) ≤ 80 mL/m².
Disqualifiers
Unable or unwilling to undergo contrast MRI.
Class I indication for permanent pacing, except for symptomatic chronotropic incompetence
Current permanent or persistent Atrial fibrillation (A-fib)
Structural heart disease requiring intervention
Trial design
Treatments tested in this trial
- Pacemaker PLR + TRT ON
- Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
Treatment groups
105 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov