Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction

NCT ID: NCT04721314

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-17
• Study Completion Date: 2021-12-05

Brief Summary

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.

Conditions

Pacemaker; Diastolic Dysfunction; Diastolic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lower rate set to a higher, personalized backup heart rate (myPACE)

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.

Group Type: EXPERIMENTAL

Adjustment of lower rate limit

Intervention Type: 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.

Lower rate left at 60 beats-per-minute

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.

Group Type: ACTIVE_COMPARATOR

Maintenance of lower rate limit

Intervention Type: DEVICE

Lower rate limit will be maintained at 60 beats-per-minute

Interventions

Adjustment of lower rate limit

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.

Intervention Type: DEVICE

Maintenance of lower rate limit

Lower rate limit will be maintained at 60 beats-per-minute

Intervention Type: DEVICE

Eligibility Criteria

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:

• dyspnea with exertion
• or NYHA Class ≥ II heart failure
• or pulmonary edema on prior chest imaging or documented on exam
• or is taking loop diuretics for heart failure
• or had NTproBNP >400 ng/ml in the last 24 months
• or a heart failure hospitalization in the last 2 years
• or has diastolic dysfunction on echo
• or has left ventricular hypertrophy on echo
• or has left atrial (LA) dilation (LA volume/BSA index >28ml/m2)

Exclusion Criteria

• Left ventricular ejection fraction < 50%
• Life expectancy < 12 months
• Symptomatic pulmonary disease on home oxygen
• Uncontrolled hypertension as defined by blood pressure >160/100 mmHg on two checks ≥15 minutes apart
• Hypertrophic cardiomyopathy
• More than moderate valvular disease
• Aortic valve replacement < 1 year
• Angina pectoris
• Creatinine > 2
• Hemoglobin < 8 g/dL
• Participation in another clinical trial or registry study
• Inability to follow up for regularly scheduled pacemaker appointments or to follow up for this study
• Pregnant patients or patients of childbearing age without reliable contraceptive agent (intra-uterine device, birth control implant, compliance with contraception injections or contraception pills) for the duration of study participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Margaret Infeld

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus Meyer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

Countries

United States

References

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 Aug 27:e252827. doi: 10.1001/jamacardio.2025.2827. Online ahead of print.

Reference Type: DERIVED

PMID: 40864451 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36723919 (View on PubMed)

Other Identifiers

00000090

Identifier Type: -

Identifier Source: org_study_id