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

University of Vermont logo

University of Vermont

Status

Completed

Conditions

Diastolic Dysfunction
Diastolic Heart Failure
Pacemaker

Treatments

Device: Adjustment of lower rate limit
Device: Maintenance of lower rate limit

Study type

Interventional

Funder types

Other

Identifiers

NCT04721314
00000090

Details and patient eligibility

About

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.

Enrollment

123 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

123 participants in 2 patient groups

Lower rate set to a higher, personalized backup heart rate (myPACE)
Experimental group
Description:
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.
Treatment:
Device: Adjustment of lower rate limit
Lower rate left at 60 beats-per-minute
Active Comparator group
Description:
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.
Treatment:
Device: Maintenance of lower rate limit

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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