Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

Launched by MEDTRONIC CARDIAC RHYTHM AND HEART FAILURE · Apr 20, 2023

Keywords

ClinConnect Summary

The FIRE-HFpEF clinical trial is exploring how certain pacing therapies might help improve the exercise ability and overall health of people with heart failure who still have a good heart function, known as preserved ejection fraction. The trial will include up to 105 participants from various locations in the United States who are diagnosed with this condition. To be eligible, participants should be between the ages of 65 and 74, have a specific heart function measurement (ejection fraction of 55% or higher), and be stable on prescribed heart failure medications for at least a month.

Those who join the study can expect to undergo evaluations to see how well the pacing therapies work for them. It’s important to note that participants will need to undergo some tests, including a contrast MRI, and certain health conditions may exclude them from taking part. This study is currently recruiting participants, and it aims to provide valuable insights into new treatments for heart failure with preserved ejection fraction.

Gender

ALL

Eligibility 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.