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Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

NCT05839730 · Medtronic Cardiac Rhythm and Heart Failure
In plain English

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About this study
After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. After 6 weeks, subjects will have a follow up visit with a blood draw and a cardiac MRI. At this visit, subjects will be randomized 2:1 for pacing therapy or as a control (programmed into either a non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest). After 3, 6 and 9 months after randomization, subjects will return for a follow up visit. At the 9-month visit therapy modifications will be made based on initial pacing randomization assignment: pacing therapy will be terminated in the original therapy group and enabled in the control group. After an additional 3-months of follow-up, subjects will return for their final visit, therapies will be disabled in all subjects and subjects will be exited. Echocardiographic, functional, and health status endpoints will be collected and analyzed to assess therapy efficacy.
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 design
Enrollment target: 105 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-09-11
Estimated completion: 2027-07
Last updated: 2026-04-27
Interventions
Device: Pacemaker PLR + TRT ONDevice: Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
Primary outcomes
  • characterize the effect of TRT + PLR on cardiac structure. LV mass, LVEDV, LVESV, and wall thickness which will be collected at baseline, 3-month, 6-month, 9-month, and 12-month visits. (Through study completion, projected for three years until last subject last 12-month visit.)
  • Characterize the effect of pacing therapies on health status, defined as change in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 3, 6, and 9 months. (Through study completion, projected for three years until last subject last 12-month visit.)
  • Characterize the durability of cardiac remodeling changes and assess the safety and tolerability of TRT + PLR. (Through study completion, projected for three years until last subject last 12-month visit.)
Sponsor
Medtronic Cardiac Rhythm and Heart Failure · industry
Contacts & investigators
ContactScott A Sarazin · contact · scott.a.sarazin@medtronic.com · 763-526-2817
All locations (8)
NCH Heart InstituteRecruiting
Naples, Florida, United States
Prairie Education and Research Cooperative-St. Elizabeth'sRecruiting
O'Fallon, Illinois, United States
Prairie Education and Research Cooperative-St. John'sRecruiting
Springfield, Illinois, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Duke UniversityRecruiting
Durham, North Carolina, United States
Oklahoma Heart HospitalRecruiting
Oklahoma City, Oklahoma, United States
Houston Methodist Research InstituteRecruiting
Houston, Texas, United States
The University of Vermont Medical CenterRecruiting
Burlington, Vermont, United States
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction · TrialPath