Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Ventricular Diastolic Function and Cerebral Blood Flow
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
研究组 & 干预措施
Conventional Lower Rate Pacing Group (60 bpm)
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.
干预措施: Standard lower rate pacing (Device)
Personalized Lower Rate Pacing Group (75 bpm)
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.
干预措施: Personalized lower rate pacing (Device)
结局指标
主要结局
Change in Ventricular Diastolic Function and Cerebral Blood Flow
时间窗: 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).
次要结局
- 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)