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

RecruitingNAAges 65 Years - anyAllMedtronic Cardiac Rhythm and Heart Failure
NCT07589452 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 functio

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📋 Eligibility rules (as published)
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
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What it tests

  • Personalized lower rate pacing
  • Standard lower rate pacing
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Where

1 site
Shanxi Cardiovascular Hospital
Taiyuan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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