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

Diastolic Dysfunction Clinical Trial

— myPACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721314
• Other study ID #: 00000090
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: December 5, 2021

Study information

• Verified date: February 2022
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 5, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic
• Pacemaker

Intervention

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.
• Maintenance of lower rate limit
Lower rate limit will be maintained at 60 beats-per-minute

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minnesota Living with Heart Failure Questionnaire Score	Change in score from baseline (at enrollment) to 1 month and 12 months after enrollment.	Baseline, 1 month, and 12 months
Secondary	NTproBNP	Change in NTproBNP level from baseline to 1 month	Baseline, 1 month
Secondary	Hospitalization or invasive outpatient intervention for heart failure		At 12 months
Secondary	Atrial Arrhythmia Burden	On pacemaker reports	At 12 months
Secondary	Loop diuretic initiation or up-titration		At 12 months
Secondary	Anti-arrhythmic initiation or up-titration		At 12 months
Secondary	Pacemaker-detected activity levels		At 12 months
Secondary	hospitalizations or invasive outpatient intervention for heart failure exacerbation, atrial tachyarrhythmias, cerebrovascular accident, or myocardial infarction		At 12 months