Heart Failure Clinical Trial

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

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.

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Full Description

After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. Subjects will then be randomized 1:1 to either the Atrial Ventricular Node Stimulation (AVNS) therapy or the control group, that will be applied for 24 hours and discontinued at the end of the 24-hour period. Serum biomarkers will be collected and analyzed. After 6 weeks, subjects will be randomized to either the full pacing therapy (TRT + PLR on) or the control group. At 7 months therapy modifications will be made based on initial pacing randomization assignment (full pacing therapy or modified pacing therapy), and a new randomization which applies pacing therapies (either full pacing therapy or modified pacing therapy) to all subjects will be applied. At 10 months all pacing therapy will have a final adjustment and subjects will be evaluated for their final visit at 12-months and exited from the study. Echocardiographic, functional, and health status endpoints will be collected and analyzed to assess therapy efficacy.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

105

Study ID:

NCT05839730

Recruitment Status:

Suspended

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There are 4 Locations for this study

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NCH Heart Institute
Naples Florida, 34102, United States
Emory University Hospital
Atlanta Georgia, 30308, United States
Prairie Education and Research Cooperative
Springfield Illinois, 62769, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

105

Study ID:

NCT05839730

Recruitment Status:

Suspended

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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