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

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.

Study Overview

• Status: Completed
• Conditions: Diastolic Heart Failure; Diastolic Dysfunction; Pacemaker
• Intervention / Treatment: Device: Adjustment of lower rate limit; Device: Maintenance of lower rate limit

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	Device: Maintenance of lower rate limit; Lower rate limit will be maintained at 60 beats-per-minute

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Vermont
• Investigators: Principal Investigator: Markus Meyer, MD, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): December 5, 2021

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Personalized; Diastolic dysfunction; Heart failure with preserved ejection fraction; Resting heart rate; Lower rate setting
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic
• Other Study ID Numbers: 00000090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes