Improving heart function in patients with preserved ejection fraction heart failure
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
This study is testing whether pacing therapy can help people with heart failure and preserved ejection fraction improve their exercise ability and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Cardiac Rhythm and Heart Failure Industry-sponsored |
| Locations | 8 sites (Naples, Florida and 7 other locations) |
| Trial ID | NCT05839730 on ClinicalTrials.gov |
What this trial studies
The FIRE-HFpEF study is a multi-center, prospective, randomized, single-blinded clinical feasibility study aimed at evaluating the effects of pacing therapies on exercise capacity and health status in patients with heart failure with preserved ejection fraction. Up to 105 subjects will be enrolled and undergo pacemaker implantation, followed by a 6-week observation period. Participants will then be randomized to receive either pacing therapy or a control mode, with follow-up visits scheduled at 3, 6, and 9 months to assess therapy efficacy through various health metrics. The study aims to gather data on the impact of pacing on heart function and patient well-being.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with heart failure, a left ventricular ejection fraction of 55% or higher, and classified as NYHA Functional Class I-III.
Not a fit: Patients with heart failure who do not meet the inclusion criteria or have contraindications for pacemaker implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise capacity and overall health status for patients with heart failure with preserved ejection fraction.
How similar studies have performed: While pacing therapies have been explored in various contexts, this specific approach in heart failure with preserved ejection fraction is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy * Severe aortic or mitral valve disease, defined as severe regurgitation or a valve area \< 1cm\^2 * Exertional angina * Severe pulmonary disease including severe Chronic obstructive pulmonary disease (COPD) (i.e., requiring home oxygen, chronic nebulizer therapy, or chronic oral steroid therapy or hospitalized for pulmonary decompensation within 12 months) * Estimated glomerular filtration rate (eGFR) \< 25 ml/min/1.73m\^2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula * Uncontrolled blood pressure, defined as systolic pressure outside the range of 100 to 160 mmHg despite anti-hypertensive medication.
Where this trial is running
Naples, Florida and 7 other locations
- NCH Heart Institute — Naples, Florida, United States (Recruiting)
- Prairie Education and Research Cooperative-St. Elizabeth's — O'Fallon, Illinois, United States (Recruiting)
- Prairie Education and Research Cooperative-St. John's — Springfield, Illinois, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States (Recruiting)
- Houston Methodist Research Institute — Houston, Texas, United States (Recruiting)
- The University of Vermont Medical Center — Burlington, Vermont, United States (Recruiting)
Study contacts
- Study coordinator: Scott A Sarazin
- Email: scott.a.sarazin@medtronic.com
- Phone: 763-526-2817
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.