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Study of Pacemaker Therapy for Heart Failure with Preserved Ejection Fraction

This study is looking at a new way to treat Heart Failure with Preserved Ejection Fraction (HFpEF), a condition where your heart can't pump enough blood even though it still squeezes well. Researchers are testing a special pacemaker called RAMware, which uses personalized lower rate (PLR) and tachycardia remodeling therapy (TRT). They want to see if this pacemaker can improve your heart's structure and how you feel. You might be able to join if you have HFpEF with a specific heart pumping strength (ejection fraction of 55% or more) and are on stable heart failure medications. The study will measure changes in your heart's size and shape, as well as your overall health and quality of life.

Study design
This is a multi-center, prospective, randomized, single-blinded study planning to enroll up to 105 participants.
What's involved
You will have a pacemaker implanted, followed by visits at 6 weeks, 3, 6, and 9 months after randomization, and a final visit after an additional 3 months. These visits will include blood draws and cardiac MRIs.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a total of 12 months after randomization, with therapies disabled at the final visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05839730

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Medtronic Cardiac Rhythm and Heart Failure
~105 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Pacemaker PLR + TRT ONPacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Through study completion, projected for three years until last subject last 12-month visit.
+2 more outcomes measured

Conditions

Heart Failure With Preserved Ejection Fraction
Concentric Hypertrophy

Explore related trials

Eccentric hypertrophyHeart failure with normal ejection fraction

Where it's being run

8 sites across 7 states
Illinois2
Florida1
Kansas1
North Carolina1
Oklahoma1
Texas1
Vermont1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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.

    The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated patient-oriented measure of the adverse effects of heart failure on a patient's life. Each of the 21 questions are scored on a 6-point Likert Scale (0 to 5), the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life.

  • 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.