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Completed

NCT Number: NCT04721314

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

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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Key information

Conditions

Pacemaker Cardiovascular Diseases Diastolic Dysfunction Diastolic Heart Failure Heart Diseases Heart Failure Heart Failure, Diastolic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Maintenance of lower rate limit

Device

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

Primary outcomes

  1. Minnesota Living with Heart Failure Questionnaire Score

    Time frame: Baseline, 1 month, and 12 months

    Change in score from baseline (at enrollment) to 1 month and 12 months after enrollment.

Secondary outcomes

  1. NTproBNP

    Time frame: Baseline, 1 month

    Change in NTproBNP level from baseline to 1 month

  2. Hospitalization or invasive outpatient intervention for heart failure

    Time frame: At 12 months

  3. Atrial Arrhythmia Burden

    Time frame: At 12 months

    On pacemaker reports

  4. Loop diuretic initiation or up-titration

    Time frame: At 12 months

  5. Anti-arrhythmic initiation or up-titration

    Time frame: At 12 months

  6. Pacemaker-detected activity levels

    Time frame: At 12 months

  7. hospitalizations or invasive outpatient intervention for heart failure exacerbation, atrial tachyarrhythmias, cerebrovascular accident, or myocardial infarction

    Time frame: At 12 months

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Acronym: myPACE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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