Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
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
| Condition(s) | Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Medtronic Cardiac Rhythm and Heart Failure |
| Locations | Naples, Florida, United States; O'Fallon, Illinois, United States; Springfield, Illinois, United States; Kansas City, Kansas, United States; Durham, North Carolina, United States; Oklahoma City, Oklahoma, United States (+2 more sites) |
| Start date | 2024-09-11 |
| NCT ID | NCT05839730 |
| Official listing | https://clinicaltrials.gov/study/NCT05839730 |