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

Not Applicable

Completed

• Conditions: Pacemaker; Diastolic Dysfunction; Diastolic Heart Failure
• Interventions: Device: Maintenance of lower rate limit; Device: Adjustment of lower rate limit

• Registration Number: NCT04721314
• Lead Sponsor: University of Vermont

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-17
• Study First Submitted: 2021-01-16
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Primary Completion: 2021-10-30
• Study Completion: 2021-12-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower rate left at 60 beats-per-minute	Maintenance of lower rate limit	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.
Lower rate set to a higher, personalized backup heart rate (myPACE)	Adjustment of lower rate limit	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.

Primary Outcome Measures

Name	Time	Method
Minnesota Living with Heart Failure Questionnaire Score	Baseline, 1 month, and 12 months	Change in score from baseline (at enrollment) to 1 month and 12 months after enrollment.

Secondary Outcome Measures

Name	Time	Method
hospitalizations or invasive outpatient intervention for heart failure exacerbation, atrial tachyarrhythmias, cerebrovascular accident, or myocardial infarction	At 12 months
NTproBNP	Baseline, 1 month	Change in NTproBNP level from baseline to 1 month
Anti-arrhythmic initiation or up-titration	At 12 months
Hospitalization or invasive outpatient intervention for heart failure	At 12 months
Loop diuretic initiation or up-titration	At 12 months
Pacemaker-detected activity levels	At 12 months
Atrial Arrhythmia Burden	At 12 months	On pacemaker reports

Trial Locations

Locations (1)

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States