Could a smart pacemaker ease a common type of heart failure?
NCT ID NCT05839730
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This study tests a modified pacemaker designed to improve heart function and quality of life in people with heart failure with preserved ejection fraction (HFpEF). About 105 participants will receive either the active pacing therapy or a non-pacing mode. Researchers will measure changes in heart structure, exercise capacity, and symptoms over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pacemaker with personalized lower rate and tachycardia remodeling therapy
- What this could lead to
- If it works, this could offer a new way to improve exercise ability and daily life for people with a common type of heart failure.
- What could go wrong
- This is an early feasibility study with only 105 people, so results may not apply to everyone. The therapy involves a device implant, which carries risks like infection or pacing discomfort.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 105 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke University
Durham, North Carolina, 27708, United States
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Houston Methodist Research Institute
Houston, Texas, 77030, United States
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NCH Heart Institute
Naples, Florida, 34102, United States
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Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
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Prairie Education and Research Cooperative-St. Elizabeth's
O'Fallon, Illinois, 62269, United States
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Prairie Education and Research Cooperative-St. John's
Springfield, Illinois, 62769, United States
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The University of Vermont Medical Center
Burlington, Vermont, 05401, United States
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University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
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