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NCT Number: NCT07589452

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

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Ventricular Diastolic Function and Cerebral Blood Flow

    Time frame: Baseline to 6 months post-implantation

    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).

Secondary outcomes

  1. Cardiac Structure and Function Assessment

    Time frame: Baseline to 6 months post-implantation

    To evaluate cardiovascular function using echocardiography and assess ventricular function, particularly diastolic function, using Doppler echocardiography.

  2. Cerebral Perfusion and Cognitive Function Assessment

    Time frame: Baseline to 6 months post-implantation

    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).

  3. Arterial Blood Pressure Assessment

    Time frame: Baseline to 6 months post-implantation

    To evaluate changes in arterial blood pressure using office blood pressure measurement and 24 hour ambulatory blood pressure monitoring.

Study contacts

Contact information is provided by the study sponsor or research team.

Georgiana Zou

CONTACT

[email protected]

+86 18918711140

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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