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Clinical Trials in the USA / NCT05839730
Active, not recruiting Not applicable

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

NCT05839730 · tracked via the Priya Life Science USA tracker
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Phase
Not applicable
Started
2024-09-11
Last updated
2026-08-03

Condition(s) studied

Heart Failure With Preserved Ejection FractionConcentric Hypertrophy

Investigational drug(s) / intervention(s)

Pacemaker PLR + TRT ONPacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.

Pacemaker PLR + TRT ON: RAMware modified implantable pulse generator (IPG) with personalized lower rate (PLR) and tachycardia remodeling therapy (TRT) ON

Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.: RAMware modified implantable pulse generator (IPG)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
NCH Heart Institute Naples Florida
Prairie Education and Research Cooperative-St. Elizabeth's O'Fallon Illinois
Prairie Education and Research Cooperative-St. John's Springfield Illinois
University of Kansas Medical Center Kansas City Kansas
Duke University Durham North Carolina
Oklahoma Heart Hospital Oklahoma City Oklahoma
Houston Methodist Research Institute Houston Texas
The University of Vermont Medical Center Burlington Vermont

More Medtronic Cardiac Rhythm and Heart Failure trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05839730 on ClinicalTrials.gov ↗ ← All trials in the USA