Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction

NCT07589452 | Not Yet Recruiting

• 1 other identifier: Allometric-Cerebral Study
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Cardiac Structure and Function Assessment

  Baseline to 6 months post-implantation

• Cerebral Perfusion and Cognitive Function Assessment

  Baseline to 6 months post-implantation

• Arterial Blood Pressure Assessment

  Baseline to 6 months post-implantation

Study Arms (2)

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.

Device: Personalized lower rate pacing

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.

Device: Standard lower rate pacing

Interventions

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.

Personalized Lower Rate Pacing Group (75 bpm)

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.

Conventional Lower Rate Pacing Group (60 bpm)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥65 years of age
• Planned implantation of a dual chamber pacemaker with physiological pacing
• Resting sinus heart rate ≤60 bpm, or average 24 hour Holter heart rate ≤60 bpm
• Documented history of hypertension or office systolic blood pressure ≥130 mmHg

You may not qualify if:

• Diagnosis of secondary hypertension
• Diagnosis of or possible concomitant heart failure, with ejection fraction ≤50%
• Paroxysmal, persistent, or permanent atrial fibrillation
• Status post CABG or PCI
• Structural heart disease
• Risk of ventricular tachyarrhythmia
• Severe hepatic or renal dysfunction
• Active acute infection
• Inability to sign informed consent
• Pregnancy or planned pregnancy during the study period
• Enrollment in other clinical studies that may affect the objectives of this study

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Related Publications (7)

• 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.

  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.

  PMID: 26402848 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.

  PMID: 31525068 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.

  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.

  PMID: 36723919 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.

  PMID: 33604585 BACKGROUND

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Georgiana Zou

CONTACT

+86 18918711140; georgiana.zou@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share