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Recent exploratory studies suggest that pacemaker patients with diastolic dysfunction (DD) or heart failure with preserved ejection fraction (HFpEF) may benefit from a higher backup heart rate (HR) setting than the factory setting of 60 beats per minute (bpm). In this prospective double-blinded randomized controlled study, pacemaker patients with DD or overt HFpEF and either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing will be enrolled and randomized to either a personalized lower HR setting (myPACE group, based on a height-based HR algorithm) or to the standard 60bpm backup setting (control group) for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower rate set to a higher, personalized backup heart rate (myPACE) | Experimental | Patients randomized to this group will have their pacemaker lower heart rate setting programmed to a personalized lower rate based on a resting heart rate algorithm. |
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| Lower rate left at 60 beats-per-minute | Active Comparator | Patients randomized to this group will have their pacemaker lower heart rate setting left at or programmed to the conventional pacemaker lower rate setting of 60bpm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjustment of lower rate limit | Device | Patients with preserved ejection fraction (EF >50%) and implanted pacemakers will have the lower rate limit adjusted to a personalized heart rate based on a heart rate algorithm. |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Living with Heart Failure Questionnaire Score | Change in score from baseline (at enrollment) to 1 month and 12 months after enrollment. | Baseline, 1 month, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| NTproBNP | Change in NTproBNP level from baseline to 1 month | Baseline, 1 month |
| Hospitalization or invasive outpatient intervention for heart failure | At 12 months |
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Inclusion Criteria:
Implanted pacemaker with either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing or 3) RV pacing <2% and paced QRS duration <150ms
Clinical evidence of heart failure with preserved ejection fraction or diastolic dysfunction, based on:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Meyer, MD, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40864451 | Derived | Infeld M, Cyr J, Novelli AE, Rawlings R, Wahlberg K, Plante TB, de Lavallaz JDF, Habel N, Lustgarten DL, Meyer M. Clinical Outcomes With Personalized Accelerated Physiologic Pacing in Heart Failure With Preserved Ejection Fraction: Follow-up of the myPACE Trial. JAMA Cardiol. 2025 Oct 1;10(10):1010-1015. doi: 10.1001/jamacardio.2025.2827. | |
| 38124404 |
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Patients are randomized to either a personalized pacemaker lower heart rate setting based on a resting heart rate algorithm or to the conventional pacemaker lower rate setting of 60bpm.
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All investigators are blinded to patient randomization. To assess subject blinding, participants are asked at 1 month and 12 month follow up if they believed that their pacemaker lower rate was changed.
| Maintenance of lower rate limit | Device | Lower rate limit will be maintained at 60 beats-per-minute |
|
| Atrial Arrhythmia Burden | On pacemaker reports | At 12 months |
| Loop diuretic initiation or up-titration | At 12 months |
| Anti-arrhythmic initiation or up-titration | At 12 months |
| Pacemaker-detected activity levels | At 12 months |
| hospitalizations or invasive outpatient intervention for heart failure exacerbation, atrial tachyarrhythmias, cerebrovascular accident, or myocardial infarction | At 12 months |
| de la Espriella R, Wahlberg KJ, Infeld M, Palau P, Nunez E, Sanchis J, Meyer M, Nunez J. Effect of paced heart rate on quality of life and natriuretic peptides for stage B or C heart failure with preserved ejection fraction: A secondary analysis of the myPACE trial. Eur J Heart Fail. 2024 Jan;26(1):167-176. doi: 10.1002/ejhf.3107. Epub 2024 Jan 2. |
| 36723919 | Derived | Infeld M, Wahlberg K, Cicero J, Plante TB, Meagher S, Novelli A, Habel N, Krishnan AM, Silverman DN, LeWinter MM, Lustgarten DL, Meyer M. Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):213-221. doi: 10.1001/jamacardio.2022.5320. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 5, 2023 | Feb 28, 2023 | 3 | ||
| Apr 23, 2023 | May 8, 2023 | |||
| May 8, 2023 | Jun 7, 2023 | 4 |
| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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