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The study is a prospective, randomized controlled study in hypertensive patients with a bradycardia indications for pacing therapy and a plan to receive dual-chamber pacemaker. Enrolled patients will be randomized 1:1 into the control group and the allometric-pace group. In the control group, the pacing lower rate will be set to the nominal 60 bpm post a dual-chamber pacemaker implantation as frequently used in clinical practice, while in the allometric-pace group, the pacing rate will be programmed at 75 bpm based on the estimation for Chinese population with a height of 165-170 cm (also called personalized lower rate) or based on the symptom-relief per clinical assessment by the study physicians. Each patient will undergo baseline assessments and 3-month follow-up visits. At the enrollment and office visits, each patient will undergo arterial blood pressure measurement, cardiac functional assessment and cerebral blood flow measurement. At the end of the study, the study physician will adjust pacing lower rate based on patients' conditions and clinical assessments. After the completion of the study, all patients will have regular device follow-up visit, usually 6-month interval or annually.
Each patient will receive the following major assessments: device performance and pacing percentages, ventricular diastolic function by doppler and echocardiography of LVEF, LVEDV, LVESV, stroke volume, cardiac output, arterial blood pressure measurements, cerebral blood flow by MRI or Echo (which one will be determined later by the study PIs), and Mini-Mental State Examination (MMSE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Lower Rate Pacing Group (75 bpm) | Experimental | Participants in this group will receive dual-chamber pacemaker implantation per standard clinical practice. After implantation, the device lower rate will be programmed to a personalized pacing rate of 75 beats per minute according to the study protocol. Ventricular diastolic function, cerebral blood flow, cognitive function, and blood pressure will be assessed during follow-up. |
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| Conventional Lower Rate Pacing Group (60 bpm) | Active Comparator | Participants in this group will receive dual-chamber pacemaker implantation per standard clinical practice. After implantation, the device lower rate will be programmed to the conventional lower pacing rate of 60 beats per minute. Outcome assessments during follow-up will be identical to those in the personalized pacing group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized lower rate pacing | Device | The intervention consists of programming the pacemaker lower rate to a personalized setting of 75 beats per minute (personalized lower rate, PLR), based on clinical assessment. The control condition uses the standard pacemaker lower rate programmed at 50-60 beats per minute. No additional procedures beyond routine clinical practice are introduced. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ventricular Diastolic Function and Cerebral Blood Flow | In hypertensive patients with sinus node dysfunction treated with dual chamber pacemaker implantation, compared with the control group (pacemaker lower rate 50-60 bpm), to verify whether ventricular diastolic function and cerebral blood flow can be improved by personalized lower rate pacing (PLR) (75 bpm). | Baseline to 6 months post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Structure and Function Assessment | To evaluate cardiovascular function using echocardiography and assess ventricular function, particularly diastolic function, using Doppler echocardiography. | Baseline to 6 months post-implantation |
| Cerebral Perfusion and Cognitive Function Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgiana Zou | Contact | +86 18918711140 | georgiana.zou@medtronic.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Changes in 24-hour ambulatory systolic blood pressure following pacemaker implantation in patients with sinus node dysfunction. Presented at the APHRS 2025 Scientific Sessions; 2025; Poster presentation. | ||
| 26402848 | Background | Meng L, Hou W, Chui J, Han R, Gelb AW. Cardiac Output and Cerebral Blood Flow: The Integrated Regulation of Brain Perfusion in Adult Humans. Anesthesiology. 2015 Nov;123(5):1198-208. doi: 10.1097/ALN.0000000000000872. | |
| 31525068 |
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| Standard lower rate pacing | Device | The control intervention consists of programming the pacemaker lower rate to the standard clinical setting of 50-60 beats per minute, according to routine clinical practice. No additional procedures or deviations from standard care are introduced. |
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To evaluate cerebral cortical blood distribution and white matter changes using magnetic resonance imaging (MRI), and to assess cognitive function using the Mini Mental State Examination (MMSE). |
| Baseline to 6 months post-implantation |
| Arterial Blood Pressure Assessment | To evaluate changes in arterial blood pressure using office blood pressure measurement and 24 hour ambulatory blood pressure monitoring. | Baseline to 6 months post-implantation |
| Background |
| Meyer M, LeWinter MM. Heart Rate and Heart Failure With Preserved Ejection Fraction: Time to Slow beta-Blocker Use? Circ Heart Fail. 2019 Aug;12(8):e006213. doi: 10.1161/CIRCHEARTFAILURE.119.006213. Epub 2019 Aug 1. No abstract available. |
| Background | Infeld M, et al. Allometric-Based Pacing Rate Improves Quality of Life in Bradycardia Patients. Presented at the HRS 2025 Scientific Sessions; 2025; Poster presentation. |
| Background | Infeld M, et al. A novel method to classify left bundle branch block with far-field intracardiac electrograms. Presented at the HRS 2025 Scientific Sessions; 2025; Poster presentation. |
| 36723919 | Background | Infeld 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. |
| 33604585 | Background | Infeld M, Avram R, Wahlberg K, Silverman DN, Habel N, Lustgarten DL, Pletcher MJ, Olgin JE, Marcus GM, Meyer M. An approach towards individualized lower rate settings for pacemakers. Heart Rhythm O2. 2020 Dec;1(5):390-393. doi: 10.1016/j.hroo.2020.09.004. Epub 2020 Oct 6. No abstract available. |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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