Actively Recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Led by Medtronic Cardiac Rhythm and Heart Failure · Updated on 2026-04-27
105
Participants Needed
8
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Heart Failure with Left Ventricular Ejection Fraction (LVEF) 55% or higher within the last year
- New York Heart Association (NYHA) Functional Class I to III
- Stable on guideline-directed medical therapy for heart failure for at least 1 month, excluding loop diuretics
- End Diastolic Volume indexed to body surface area (BSA) 80 mL/m2 or less
- Evidence of concentric remodeling or hypertrophy with at least one of the following:
- LV posterior or lateral wall thickness greater than 11 mm
- Relative wall thickness greater than 0.42
- Male with LV mass indexed to BSA 115 g/m2 or higher
- Male with LV mass indexed to height 49.2 g/m2.7 or higher
- Female with LV mass indexed to BSA 95 g/m2 or higher
- Female with LV mass indexed to height 46.7 g/m2.7 or higher
You will not qualify if you...
- Unable or unwilling to undergo contrast MRI
- Class I indication for permanent pacing, except for symptomatic chronotropic incompetence
- Current permanent or persistent atrial fibrillation
- 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 valve area less than 1 cm2
- Exertional angina
- Severe pulmonary disease including severe COPD requiring home oxygen, chronic nebulizer or oral steroid therapy, or recent hospitalization for pulmonary issues
- Estimated glomerular filtration rate (eGFR) less than 25 ml/min/1.73m2
- Uncontrolled blood pressure with systolic pressure outside 100 to 160 mmHg despite medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
NCH Heart Institute
Naples, Florida, United States, 34102
Actively Recruiting
2
Prairie Education and Research Cooperative-St. Elizabeth's
O'Fallon, Illinois, United States, 62269
Actively Recruiting
3
Prairie Education and Research Cooperative-St. John's
Springfield, Illinois, United States, 62769
Actively Recruiting
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
5
Duke University
Durham, North Carolina, United States, 27708
Actively Recruiting
6
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
7
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
8
The University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
Research Team
S
Scott A Sarazin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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