PacemakermyPACENCT04721314
Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
A study testing Adjustment of lower rate limit and Maintenance of lower rate limit in people with Pacemaker and Diastolic Dysfunction, run by University of Vermont at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker, Diastolic Dysfunction, Diastolic Heart Failure
- What is being tested?
- Adjustment of lower rate limit and Maintenance of lower rate limit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2019to 5 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
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.
- Conditions
- Pacemaker, Diastolic Dysfunction, Diastolic Heart Failure
- Being tested
- Adjustment of lower rate limit, Maintenance of lower rate limit
- Keywords
- Heart failure with preserved ejection fraction, Diastolic dysfunction, Resting heart rate, Personalized, Lower rate setting
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustment of lower rate limitDevice
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 limitDevice
Lower rate limit will be maintained at 60 beats-per-minute
| Study group | Role | What they receive |
|---|---|---|
| Lower rate set to a higher, personalized backup heart rate (myPACE) | 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. Receives: Device: Adjustment of lower rate limit |
| Lower rate left at 60 beats-per-minute | 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. Receives: Device: Maintenance of lower rate limit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minnesota Living with Heart Failure Questionnaire Score
Change in score from baseline (at enrollment) to 1 month and 12 months after enrollment.
Measured: Baseline, 1 month, and 12 months
Secondary outcomes (7)
NTproBNP
Change in NTproBNP level from baseline to 1 month
Measured: Baseline, 1 month
Hospitalization or invasive outpatient intervention for heart failure
Measured: At 12 months
Atrial Arrhythmia Burden
On pacemaker reports
Measured: At 12 months
Loop diuretic initiation or up-titration
Measured: At 12 months
Anti-arrhythmic initiation or up-titration
Measured: At 12 months
Pacemaker-detected activity levels
Measured: At 12 months
hospitalizations or invasive outpatient intervention for heart failure exacerbation, atrial tachyarrhythmias, cerebrovascular accident, or myocardial infarction
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start17 Jul 2019
- Primary completion30 Oct 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Infeld, University of Vermont
- Investigators
- Markus Meyer, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721314
- Sponsor's protocol ID
- 00000090
- Acronym
- myPACE
- Status last verified
- Feb 2022
- First submitted
- 16 Jan 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Infeld M, Cyr J, Novelli AE, Rawlings R, Wahlberg K, Plante TB, de Lavallaz JDF, Habel N, Lustgarten DL, Meyer M. Clinical Outcomes With Personalized Accelerated Physiologic Pacing in Heart Failure With Preserved Ejection Fraction: Follow-up of the myPACE Trial. JAMA Cardiol. 2025 Oct 1;10(10):1010-1015. doi: 10.1001/jamacardio.2025.2827.
PubMed 40864451de la Espriella R, Wahlberg KJ, Infeld M, Palau P, Nunez E, Sanchis J, Meyer M, Nunez J. Effect of paced heart rate on quality of life and natriuretic peptides for stage B or C heart failure with preserved ejection fraction: A secondary analysis of the myPACE trial. Eur J Heart Fail. 2024 Jan;26(1):167-176. doi: 10.1002/ejhf.3107. Epub 2024 Jan 2.
PubMed 38124404Infeld M, Wahlberg K, Cicero J, Plante TB, Meagher S, Novelli A, Habel N, Krishnan AM, Silverman DN, LeWinter MM, Lustgarten DL, Meyer M. Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):213-221. doi: 10.1001/jamacardio.2022.5320.
PubMed 36723919
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT04721314
- Acronym / sponsor ID
- myPACE / 00000090
- Conditions
- Pacemaker, Diastolic Dysfunction, Diastolic Heart Failure
- Keywords
- Heart failure with preserved ejection fraction, Diastolic dysfunction, Resting heart rate, Personalized, Lower rate setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lower rate set to a higher, personalized backup heart rate (myPACE) | Experimental | Device: Adjustment of lower rate limitPatients 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. |
| Lower rate left at 60 beats-per-minute | Active comparator | Device: Maintenance of lower rate limitPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjustment of lower rate limitPatients 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. | Device | Lower rate set to a higher, personalized backup heart rate (myPACE) |
| Maintenance of lower rate limitLower rate limit will be maintained at 60 beats-per-minute | Device | Lower rate left at 60 beats-per-minute |
Primary outcome
Minnesota Living with Heart Failure Questionnaire Score
Time frame: Baseline, 1 month, and 12 months
Change in score from baseline (at enrollment) to 1 month and 12 months after enrollment.
7 secondary outcomes
NTproBNP
Time frame: Baseline, 1 month
Hospitalization or invasive outpatient intervention for heart failure
Time frame: At 12 months
Atrial Arrhythmia Burden
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Derived from this study: PubMed 40864451Infeld M, Cyr J, Novelli AE, Rawlings R, Wahlberg K, Plante TB, de Lavallaz JDF, Habel N, Lustgarten DL, Meyer M. Clinical Outcomes With Personalized Accelerated Physiologic Pacing in Heart Failure With Preserved Ejection Fraction: Follow-up of the myPACE Trial. JAMA Cardiol. 2025 Oct 1;10(10):1010-1015. doi: 10.1001/jamacardio.2025.2827.
- Derived from this study: PubMed 38124404de la Espriella R, Wahlberg KJ, Infeld M, Palau P, Nunez E, Sanchis J, Meyer M, Nunez J. Effect of paced heart rate on quality of life and natriuretic peptides for stage B or C heart failure with preserved ejection fraction: A secondary analysis of the myPACE trial. Eur J Heart Fail. 2024 Jan;26(1):167-176. doi: 10.1002/ejhf.3107. Epub 2024 Jan 2.
- Derived from this study: PubMed 36723919Infeld M, Wahlberg K, Cicero J, Plante TB, Meagher S, Novelli A, Habel N, Krishnan AM, Silverman DN, LeWinter MM, Lustgarten DL, Meyer M. Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):213-221. doi: 10.1001/jamacardio.2022.5320.
- Individual participant dataSharing planned: No
Related trials for Pacemaker
Recruiting
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
Heart Failure
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
Not yet recruiting
Ultrasound Guided Leadless Pacemaker Implantation
Leadless Pacemaker, Transthoracic Echocardiography
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Meyer, MD, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustment of lower rate limit and Maintenance of lower rate limit in people with Pacemaker and Diastolic Dysfunction, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minnesota Living with Heart Failure Questionnaire Score (time frame: Baseline, 1 month, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04721314, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.