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

Primary Purpose

Pacemaker, Diastolic Dysfunction, Diastolic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adjustment of lower rate limit
Maintenance of lower rate limit
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pacemaker focused on measuring Heart failure with preserved ejection fraction, Diastolic dysfunction, Resting heart rate, Personalized, Lower rate setting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Vermont Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lower rate set to a higher, personalized backup heart rate (myPACE)

Lower rate left at 60 beats-per-minute

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2021
Last Updated
February 8, 2022
Sponsor
University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT04721314
Brief Title
Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
Acronym
myPACE
Official Title
Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
December 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pacemaker, Diastolic Dysfunction, Diastolic Heart Failure
Keywords
Heart failure with preserved ejection fraction, Diastolic dysfunction, Resting heart rate, Personalized, Lower rate setting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower rate set to a higher, personalized backup heart rate (myPACE)
Arm Type
Experimental
Arm 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.
Arm Title
Lower rate left at 60 beats-per-minute
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Adjustment of lower rate limit
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Maintenance of lower rate limit
Intervention Description
Lower rate limit will be maintained at 60 beats-per-minute
Primary Outcome Measure Information:
Title
Minnesota Living with Heart Failure Questionnaire Score
Description
Change in score from baseline (at enrollment) to 1 month and 12 months after enrollment.
Time Frame
Baseline, 1 month, and 12 months
Secondary Outcome Measure Information:
Title
NTproBNP
Description
Change in NTproBNP level from baseline to 1 month
Time Frame
Baseline, 1 month
Title
Hospitalization or invasive outpatient intervention for heart failure
Time Frame
At 12 months
Title
Atrial Arrhythmia Burden
Description
On pacemaker reports
Time Frame
At 12 months
Title
Loop diuretic initiation or up-titration
Time Frame
At 12 months
Title
Anti-arrhythmic initiation or up-titration
Time Frame
At 12 months
Title
Pacemaker-detected activity levels
Time Frame
At 12 months
Title
hospitalizations or invasive outpatient intervention for heart failure exacerbation, atrial tachyarrhythmias, cerebrovascular accident, or myocardial infarction
Time Frame
At 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Meyer, MD, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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