NCT04309175Unknown不适用
Effect of Long-term Atrial Pacing on Central Blood Pressure in Permanently Paced Sick Sinus Syndrome Patients With Primary Arterial Hypertension
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 主要终点
- systolic blood pressure amplification change
研究概览
简要总结
This is a randomized controlled single-centre clinical trial with a cross-over design to compare non-invasively evaluated central blood pressure and related parametres in sick sinus syndrome patients with hypertension who are paced long-term at a slower vs faster heart rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years
- •sick sinus syndrome
- •permanent cardiac pacemaker with right atrial and right ventricular leads
- •at least 3 months from implantation
- •sinus rhythm
- •percentage of atrial pacing at or above 80% since last interrogation
- •percentage of ventricular pacing at or below 3% since last interrogation
- •primary arterial hypertension
- •antihypertensive drug treatment
- •mean office brachial blood pressure below 140/90 mmHg
- •mean home brachial blood pressure below 135/85 mmHg
- •ability to understand and follow study protocol
- •signed informed consent form
排除标准
- •inclusion criteria not fulfilled
- •violation of study protocol by subject, investigator or third part
- •high quality central hemodynamic measurements cannot be perfomed
- •inter-arm difference in brachial systolic blood pressure 15 mmHg or above
- •intrinsic QRS complex 130 ms or above
- •more than three antihypertensive agents in use
- •treatment with digoxin or agents from Vaughan-Williams classes Ic, III või IV
- •frequent high atrial rate episodes
- •coronary artery disease
- •secondary hypertension
- •resistant hypertension
- •orthostatic hypotension
- •heart failure with decreased or preserved left ventricular ejection fraction
- •implantable cardioverter-defibrillator or cardiac resynchronization therapy
- •significant valvular heart disease
- •significant congenital heart disease
- •body mass index ≥35 kg/m2
- •type I diabetes
- •type II diabetes with cardiovascular complications or on insulin therapy
- •other significant endocrine disease
- •history of cerebrovascular attack
- •carotid artery disease
- •lower extremity arterial disease
- •severe chronic obstructive pulmonary disease
- •severe asthma
- •severe sleep apnea
- •interstitial pulmonary disease
- •inhaled beta adrenergic agonist therapy
- •active cancer treatment
- •central nervous system degenerative disease
- •systemic connective tissue disease
- •abnormal TSH at present
- •glomerular filtration rate ≤30 ml/min/m2
- •hemoglobin <100 g/L (female), <110 g/L (male)
- •hepatic dysfunction
- •alcohol abuse
- •pregnancy or breastfeeding
- •no health insurance provided by Estonian Health Insurance Fund
- •withdrawal of informed consent
- •loss of contact with a subject during study
研究组 & 干预措施
Slow-Fast
Experimental
干预措施: base rate programming of a permanent cardiac pacemaker (Device)
Fast-Slow
Experimental
干预措施: base rate programming of a permanent cardiac pacemaker (Device)
结局指标
主要结局
systolic blood pressure amplification change
时间窗: two months
次要结局
未报告次要终点
研究者
Tuuli Teeäär
cardiologist
Tartu University Hospital
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