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

Sponsor

University of Vermont (Other)

Overall Status

Completed

CT.gov ID

NCT04721314

Collaborator

(none)

123

Enrollment

Location

Arms

28.6

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker Diastolic Dysfunction Diastolic Heart Failure	Device: Adjustment of lower rate limit Device: Maintenance of lower rate limit	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients are randomized to either a personalized pacemaker lower heart rate setting based on a resting heart rate algorithm or to the conventional pacemaker lower rate setting of 60bpm.Patients are randomized to either a personalized pacemaker lower heart rate setting based on a resting heart rate algorithm or to the conventional pacemaker lower rate setting of 60bpm.

Masking:

Double (Participant, Investigator)

Masking Description:

All investigators are blinded to patient randomization. To assess subject blinding, participants are asked at 1 month and 12 month follow up if they believed that their pacemaker lower rate was changed.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 17, 2019

Actual Primary Completion Date :

Oct 30, 2021

Actual Study Completion Date :

Dec 5, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

NTproBNP [Baseline, 1 month]
Change in NTproBNP level from baseline to 1 month
Hospitalization or invasive outpatient intervention for heart failure [At 12 months]
Atrial Arrhythmia Burden [At 12 months]
On pacemaker reports
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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