Heart Failure, DiastolicPACE HFpEFNCT04546555
Physiologic Accelerated Pacing as a Treatment in Patients With Heart Failure With Preserved Ejection Fraction
A study testing Dual chamber pacemaker, Accelerated Physiologic Pacing and Nocturnal Pacing in people with Heart Failure, Diastolic, run by Daniel L Lustgarten at 1 site in United States.
Trial summary
Part I: Week 0-12: Quantify the effects of lower heart rate (HR) elevation on symptoms and function in patients with heart failure with preserved ejection fraction (HFpEF). The investigators hypothesize that a personalized lower HR elevation employing physiological conduction system pacing in patients with HFpEF will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic
- What is being tested?
- Dual chamber pacemaker, Accelerated Physiologic Pacing and Nocturnal Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2021to 25 May 2023
- 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
- Left ventricular ejection fraction ≥ 55% (and diastolic volume < 80ml/m2)
- Controlled blood pressure: average blood pressure <130/80 mmHg on office visits in the last 30 days or on home blood pressure log or patient has completed up-titration of antihypertensive medications
- Heart failure hospitalization within the past 12 months OR Echocardiogram within the past 24 months that reported left ventricular hypertrophy AND an NTproBNP >400 with at least one symptom of heart failure (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea) and at least one sign of heart failure in the past 12 months (pulmonary edema or pleural effusion on chest x-ray, lower extremity edema, jugular venous distention, rales).
- Study candidates are expected to remain available for follow-up visits.
Who cannot join
- Subject has an implanted cardiac pacemaker or defibrillator
- Life expectancy is less than 12 months
- Subject is unable or unwilling to perform the 6 Minute Walk Test and MLHFQ at all scheduled follow up visits
- Subject has any of the following: uncontrolled hypertension (average blood pressure of >140/90 on office visits in the last 30 days or on home blood pressure log or actively undergoing uptitration of antihypertensive medication), more than moderate valvular disease, chronic hypoxic respiratory failure requiring supplemental oxygen, long-standing persistent atrial fibrillation
- Baseline ECG with non-LBBB morphology AND QRS >150ms
- Subject is currently enrolled or planning to enroll in a potentially confounding trial during the course of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Part I: Week 0-12: Quantify the effects of lower heart rate (HR) elevation on symptoms and function in patients with heart failure with preserved ejection fraction (HFpEF).
The investigators hypothesize that a personalized lower HR elevation employing physiological conduction system pacing in patients with HFpEF will decrease left atrial and left ventricular filling pressures. The investigators expect that this will result in a symptomatic and functional improvements and reduce NTproBNP levels. Additionally, HR elevation may have the potential to reduce the risk for heart failure hospitalization, atrial fibrillation (AF), and cerebrovascular stroke as these outcomes are increased in patients with a normal or preserved ejection fraction on HR lowering treatments.
Read more
After undergoing pacemaker implantation participants will be randomized to one out of three treatment arms (a) Bachmann's bundle pacing, (b) Bachmann's bundle and His bundle pacing, (c) no pacing with cross-over to alternative treatment arm at week 4 and 8, respectively. The lower pacing rate in arms a and b will be programmed to the personalized lower heart rate for 24 hours a day (the patient's intrinsic heart rate can exceed the personalized lower rate limit).
Part II: Week 13-20: Determine the effects of nocturnal heart rate elevation on symptoms and function in patients with HFpEF.
The investigators hypothesize that a moderate HR elevation to 110bpm delivered for 10 hours between 8PM to 6AM will provide additional hemodynamic benefits and will lead to beneficial ventricular remodeling.
After week 12 the participant will undergo randomization to one of two treatment arms (a) Bachmann's bundle and His bundle pacing, (b) Bachmann's bundle pacing, His bundle pacing and nocturnal pacing. The participant will cross-over to the other treatment arm after 4 weeks (study week 16).
- Conditions
- Heart Failure, Diastolic
- Being tested
- Dual chamber pacemaker, Accelerated Physiologic Pacing, Nocturnal Pacing
- Keywords
- Physiologic Pacing, His Bundle Pacing, Bachmann's Bundle Pacing, HFpEF
- 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.
Dual chamber pacemakerDevice
Dual chamber pacemaker implantation with Bachmann's bundle lead and His bundle lead placement.
Accelerated Physiologic PacingOther
The lower rate limit will be programmed to an individualized heart rate.
Nocturnal PacingOther
In addition to adjustment of the lower rate limit to an individualized heart rate, nocturnal pacing a moderate HR elevation of 110bpm will be implemented between 8pm and 6am.
| Study group | Role | What they receive |
|---|---|---|
| No pacing | Placebo comparator | Not described Receives: Device: Dual chamber pacemaker |
| Bachmann's bundle pacing | Experimental | Not described Receives: Device: Dual chamber pacemaker; Other: Accelerated Physiologic Pacing |
| Bachmann's bundle and His bundle pacing | Experimental | Not described Receives: Device: Dual chamber pacemaker; Other: Accelerated Physiologic Pacing |
| Bachmann's bundle, His bundle and nocturnal pacing | Experimental | Not described Receives: Device: Dual chamber pacemaker; Other: Accelerated Physiologic Pacing; Other: Nocturnal Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in composite Minnesota-Living-with-Heart-Failure-Questionnaire score
Total score can range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life
Measured: At 1 month, 2 months, 3 months, 4 months and 5 months
Percent change in NTproBNP
Measured: At 1 month, 2 months, 3 months, 4 months and 5 months
Secondary outcomes (5)
Change in 6 minute walk test
Measured: At 1 month, 2 months, 3 months, 4 months and 5 months
Incident AF
Measured: At 1 month, 2 months, 3 months, 4 months and 5 months
Burden of AF
Measured: At 1 month, 2 months, 3 months, 4 months and 5 months
Hemodynamic changes by Echo
Measured: At 3 months and at 5 months
Change in left ventricular mass/volume ratio by cardiac MRI
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start23 Feb 2021
- Primary completion16 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel L Lustgarten
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Daniel L Lustgarten, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546555
- Sponsor's protocol ID
- 00000988
- Acronym
- PACE HFpEF
- Status last verified
- Jul 2023
- First submitted
- 31 Aug 2020
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Accelerated Pacing as a Treatment in Patients With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT04546555
- Acronym / sponsor ID
- PACE HFpEF / 00000988
- Conditions
- Heart Failure, Diastolic
- Keywords
- Physiologic Pacing, His Bundle Pacing, Bachmann's Bundle Pacing, HFpEF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Daniel L LustgartenUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 14 Sep 2020 (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.
Part I: Week 0-12: Quantify the effects of lower heart rate (HR) elevation on symptoms and function in patients with heart failure with preserved ejection fraction (HFpEF).
The investigators hypothesize that a personalized lower HR elevation employing physiological conduction system pacing in patients with HFpEF will decrease left atrial and left ventricular filling pressures. The investigators expect that this will result in a symptomatic and functional improvements and reduce NTproBNP levels. Additionally, HR elevation may have the potential to reduce the risk for heart failure hospitalization, atrial fibrillation (AF), and cerebrovascular stroke as these outcomes are increased in patients with a normal or preserved ejection fraction on HR lowering treatments.
After undergoing pacemaker implantation participants will be randomized to one out of three treatment arms (a) Bachmann's bundle pacing, (b) Bachmann's bundle and His bundle pacing, (c) no pacing with cross-over to alternative treatment arm at week 4 and 8, respectively. The lower pacing rate in arms a and b will be programmed to the personalized lower heart rate for 24 hours a day (the patient's intrinsic heart rate can exceed the personalized lower rate limit).
Part II: Week 13-20: Determine the effects of nocturnal heart rate elevation on symptoms and function in patients with HFpEF.
The investigators hypothesize that a moderate HR elevation to 110bpm delivered for 10 hours between 8PM to 6AM will provide additional hemodynamic benefits and will lead to beneficial ventricular remodeling.
After week 12 the participant will undergo randomization to one of two treatment arms (a) Bachmann's bundle and His bundle pacing, (b) Bachmann's bundle pacing, His bundle pacing and nocturnal pacing. The participant will cross-over to the other treatment arm after 4 weeks (study week 16).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No pacing | Placebo comparator | Device: Dual chamber pacemaker |
| Bachmann's bundle pacing | Experimental | Device: Dual chamber pacemaker, Other: Accelerated Physiologic Pacing |
| Bachmann's bundle and His bundle pacing | Experimental | Device: Dual chamber pacemaker, Other: Accelerated Physiologic Pacing |
| Bachmann's bundle, His bundle and nocturnal pacing | Experimental | Device: Dual chamber pacemaker, Other: Accelerated Physiologic Pacing, Other: Nocturnal Pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Left ventricular ejection fraction ≥ 55% (and diastolic volume < 80ml/m2)
- Controlled blood pressure: average blood pressure <130/80 mmHg on office visits in the last 30 days or on home blood pressure log or patient has completed up-titration of antihypertensive medications
- Heart failure hospitalization within the past 12 months OR Echocardiogram within the past 24 months that reported left ventricular hypertrophy AND an NTproBNP >400 with at least one symptom of heart failure (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea) and at least one sign of heart failure in the past 12 months (pulmonary edema or pleural effusion on chest x-ray, lower extremity edema, jugular venous distention, rales).
- Study candidates are expected to remain available for follow-up visits.
Key exclusion criteria (6 listed)
- Subject has an implanted cardiac pacemaker or defibrillator
- Life expectancy is less than 12 months
- Subject is unable or unwilling to perform the 6 Minute Walk Test and MLHFQ at all scheduled follow up visits
- Subject has any of the following: uncontrolled hypertension (average blood pressure of >140/90 on office visits in the last 30 days or on home blood pressure log or actively undergoing uptitration of antihypertensive medication), more than moderate valvular disease, chronic hypoxic respiratory failure requiring supplemental oxygen, long-standing persistent atrial fibrillation
- Baseline ECG with non-LBBB morphology AND QRS >150ms
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 |
|---|---|---|
| Dual chamber pacemakerDual chamber pacemaker implantation with Bachmann's bundle lead and His bundle lead placement. | Device | Bachmann's bundle and His bundle pacing, Bachmann's bundle pacing, Bachmann's bundle, His bundle and nocturnal pacing, No pacing |
| Accelerated Physiologic PacingThe lower rate limit will be programmed to an individualized heart rate. | Other | Bachmann's bundle and His bundle pacing, Bachmann's bundle pacing, Bachmann's bundle, His bundle and nocturnal pacing |
| Nocturnal PacingIn addition to adjustment of the lower rate limit to an individualized heart rate, nocturnal pacing a moderate HR elevation of 110bpm will be implemented between 8pm and 6am. | Other | Bachmann's bundle, His bundle and nocturnal pacing |
Primary outcome
Change in composite Minnesota-Living-with-Heart-Failure-Questionnaire score
Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months
Total score can range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life
Percent change in NTproBNP
Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months
5 secondary outcomes
Change in 6 minute walk test
Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months
Incident AF
Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months
Burden of AF
Time frame: At 1 month, 2 months, 3 months, 4 months and 5 months
Hemodynamic changes by Echo
Time frame: At 3 months and at 5 months
Change in left ventricular mass/volume ratio by cardiac MRI
Time frame: 5 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 28 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual chamber pacemaker, Accelerated Physiologic Pacing and Nocturnal Pacing in people with Heart Failure, Diastolic, run by Daniel L Lustgarten 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 4 inclusion and 6 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 28 Jul 2023. 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. Some participants in this study may receive a placebo. 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?
Change in composite Minnesota-Living-with-Heart-Failure-Questionnaire score (time frame: At 1 month, 2 months, 3 months, 4 months and 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2023.