Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction (NCT05839730) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
United States105 participantsStarted 2024-09-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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/m\^2.
* Concentric remodeling or concentric hypertrophy defined as at least one of the following criteria:
* Left ventricular (LV) posterior or lateral wall thickness \> 11mm
* Relative wall thickness (RWT) \> 0.42
* Male and LV mass indexed to BSA ≥115 g/m2
* Male and LV mass indexed to height ≥ 49.2 g/m2.7
* Female and LV mass indexed to BSA ≥ 95 g/m2
* Female and LV mass indexed to height ≥ 46.7 g/m2.7
Exclusion Criteria:
* 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
* Aortic valve replacement procedure less than 12 months prior to enrollment
* K…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: Through study completion, projected for three years until last subject last 12-month visit.
2
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.
Timeframe: Through study completion, projected for three years until last subject last 12-month visit.
3
Characterize the durability of cardiac remodeling changes and assess the safety and tolerability of TRT + PLR.
Timeframe: Through study completion, projected for three years until last subject last 12-month visit.