Completed

myPACEPersonalized Pacing for Diastolic Dysfunction or Heart Failure with Preserved Ejection Fraction

Study Aim

This study aims to evaluate the effectiveness of Personalized Pacing as a treatment for Diastolic Dysfunction or Heart Failure with Preserved Ejection Fraction, by observing changes in the Minnesota Living with Heart Failure Questionnaire Score from the start of the study to 1 month and 12 months later.

What is being tested

Adjustment of lower rate limit

+ Maintenance of lower rate limit

Device

Who is being recruted

Cardiovascular Diseases+1

+ Heart Diseases

+ Heart Failure

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: July 2019

See protocol details

Summary

Principal SponsorUniversity of Vermont

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 17, 2019

Actual date on which the first participant was enrolled.

This study focuses on individuals with diastolic dysfunction (DD) or heart failure with preserved ejection fraction (HFpEF) who have pacemakers. The main goal is to explore if these patients can benefit from a higher backup heart rate setting on their pacemakers, as compared to the standard setting of 60 beats per minute. This research is important as it aims to improve the quality of life for those with DD or HFpEF, potentially offering a new approach to their care. In this study, participants with DD or HFpEF, and either intrinsic ventricular conduction or conduction system or biventricular pacing, will be randomly assigned to one of two groups. One group will have their pacemakers set to a personalized lower heart rate (myPACE group), calculated using a height-based algorithm. The other group will maintain the standard 60 beats per minute setting (control group). The study will last for 1 year. The results will be measured using the Minnesota Living with Heart Failure Questionnaire. This survey will be completed at the start of the study, after 1 month, and after 12 months, to see if there are any changes in the participants' quality of life.

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

NCT04721314

Principal SponsorUniversity of Vermont

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

123 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart FailureHeart Failure, Diastolic

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Active Comparator

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Vermont Medical Center

Burlington, United StatesOpen University of Vermont Medical Center in Google Maps

CompletedOne Study Center