NCT03245996已完成4 期
The Impact of Heart Rate on Central Hemodynamics in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- First part of the study: central systolic blood pressure
研究概览
简要总结
This study is divided into two parts:
- The first part evaluates the acute effect of non-pharmacological heart rate change on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker
- The second part evaluates the acute effects of atenolol, nebivolol and ivabradine on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker at different pacing rate levels
详细描述
Patients with sick sinus syndrome and a double-chamber cardiac pacemaker are studied.
- To investigate the role of non-pharmacological heart rate change on central hemodynamics in the first part of the study, the investigators acutely change pacing rate from atrial paced-atrial sensed (AAI)-mode 60 to 40 to 90 bpm and obtain hemodynamic parameters noninvasively after a short stabilisation period after each pacemaker rate change.
- Subsequently, to investigate the acute effects of beta-blockers or ivabradine on central hemodynamics in the second part of the study, the investigators obtain central hemodynamic parameters noninvasively after acute administration of atenolol, nebivolol or ivabradine at the same pacing rate levels used in the first part of the study (AAI-mode 60, 40 and 90 bpm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75 years;
- •dual-chamber pacemaker implanted due to sick sinus syndrome at least six months before; sinus rhythm
排除标准
- •average seated office brachial systolic BP ≥160 mmHg and/or diastolic BP ≥ 100 mmHg; atrial pacing <40%;
- •ventricular pacing >25%;
- •unpaced QRS >120 ms and/or QTc >500 ms on 12-lead ECG;
- •atrioventricular blockage at AAI-mode 90 bpm; resting HR >60 bpm at AAI-mode 40 bpm; irregular heart rate;
- •automatic mode switching >10%;
- •implantable cardioverter defibrillator or cardiac resynchronisation therapy pacemaker; treatment with digoxin, class Ic or III antiarrhythmic drugs;
- •history of acute coronary syndrome;
- •stable angina pectoris;
- •heart failure with reduced left ventricular ejection fraction;
- •history of cerebrovascular event;
- •diabetes mellitus;
- •chronic kidney disease with eGFR <30 ml/min/m2;
- •peripheral artery disease;
- •clinically relevant heart valve disease;
- •active cancer;
- •acute or chronic inflammatory disease;
- •severe chronic respiratory or liver disease;
- •pregnancy or breastfeeding
- •contraindication or intolerance to atenolol, nebivolol, ivabradine or adjuvants
研究组 & 干预措施
Subjects
Experimental
Subjects with a cardiac pacemaker
干预措施: AAI 40 bpm (Device)
Subjects
Experimental
Subjects with a cardiac pacemaker
干预措施: AAI 60 bpm (Device)
Subjects
Experimental
Subjects with a cardiac pacemaker
干预措施: AAI 90 bpm (Device)
Subjects
Experimental
Subjects with a cardiac pacemaker
干预措施: Atenolol Pill (Drug)
Subjects
Experimental
Subjects with a cardiac pacemaker
干预措施: Nebivolol Pill (Drug)
Subjects
Experimental
Subjects with a cardiac pacemaker
干预措施: Ivabradine Pill (Drug)
结局指标
主要结局
First part of the study: central systolic blood pressure
时间窗: 3 minutes after heart rate change
Second part of the study: systolic blood pressure amplification
时间窗: 3 hours after drug administration and 3 minutes after heart rate change
difference between peripheral and central systolic blood pressure
次要结局
未报告次要终点
研究者
Tuuli Teeäär
PhD Student, cardiologist
Tartu University Hospital
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