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

NCT04721314 | Completed FDA Device

• 1 other identifier: 00000090
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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

Keywords

Heart failure with preserved ejection fraction; Diastolic dysfunction; Resting heart rate; Personalized; Lower rate setting

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• NTproBNP

  Baseline, 1 month

• Hospitalization or invasive outpatient intervention for heart failure

  At 12 months

• Atrial Arrhythmia Burden

  At 12 months

• Loop diuretic initiation or up-titration

  At 12 months

• Anti-arrhythmic initiation or up-titration

  At 12 months

Study Arms (2)

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.

Device: Adjustment of lower rate limit

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.

Device: Maintenance of lower rate limit

Interventions

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.

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

Maintenance of lower rate limit DEVICE

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

Lower rate left at 60 beats-per-minute

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (2)

• 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.

  PMID: 40864451 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.

  PMID: 36723919 DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Markus Meyer, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 22, 2021
• Study Start: July 17, 2019
• Primary Completion: October 30, 2021
• Study Completion: December 5, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)