NCT05839730 · Medtronic Cardiac Rhythm and Heart Failure
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
(FIRE-HFpEF)
What this study is about
FIRE-HFpEF is a multi-center, forward-looking, randomly assigned, 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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Naples, Florida
- O'Fallon, Illinois
- Springfield, Illinois
- Kansas City, Kansas
- Durham, North Carolina
- Oklahoma City, Oklahoma
- Houston, Texas
- Burlington, Vermont
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations