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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
123
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 limit will be maintained at 60 beats-per-minute
University of Vermont Medical Center
Burlington, Vermont, United States
Minnesota Living with Heart Failure Questionnaire Score
Change in score from baseline (at enrollment) to 1 month and 12 months after enrollment.
Time frame: Baseline, 1 month, and 12 months
NTproBNP
Change in NTproBNP level from baseline to 1 month
Time frame: Baseline, 1 month
Hospitalization or invasive outpatient intervention for heart failure
Time frame: At 12 months
Atrial Arrhythmia Burden
On pacemaker reports
Time frame: At 12 months
Loop diuretic initiation or up-titration
Time frame: At 12 months
Anti-arrhythmic initiation or up-titration
Time frame: At 12 months
Pacemaker-detected activity levels
Time frame: At 12 months
hospitalizations or invasive outpatient intervention for heart failure exacerbation, atrial tachyarrhythmias, cerebrovascular accident, or myocardial infarction
Time frame: At 12 months
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