NCT02373163已完成4 期
Characterization of Arterial Hypertension and Efficacy of Blood-pressure Lowering Therapy at Different Altitudes Above Sea Level
Prevencion1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2014年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks
研究概览
简要总结
This trial is designed to:
- Assess the response to montherapy with : a thiazide diuretic (HCTZ), a calcium-channel blocker (CCB, amlodipine) and an angiotensin-receptor blocker (telmisartan), among hypertensive subjects who live at sea level, at medium altitude above sea level and at high altitude above sea level.
- To test whether diferentes exist in the response to therapy among subjects who live at different altitude above sea level
- To assess the hemodynamic characteristics of hypertension in populations that live at sea level, at medium altitude above sea level, and at high altitude above sea level.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45-75 years. Enrollment will be stratified by age group (50-65 and 66-80 years), gender and altitude above sea level
- •Leaving in the enrollment cities for at least 2 years
- •Untreated hypertension for at least 2 weeks
- •Systolic BP between 140 and 160 mmHg and/or diastolic BP between 90 and 99 mmHg, in the absence of therapy.
排除标准
- •Diabetes mellitus.
- •Chronic kidney disease (estimated glomerular filtration rate <60 ml / minute / 1.73 m2 of body surface area.
- •Lung disease, liver disease or active cancer
- •Any factor that, in the opinion of the investigator, decreases short-term survival
- •Psychiatric illness
- •Inability to provide informed consent
- •Established heart disease (previous myocardial infarction, heart failure, valvular heart disease, cardiomyopathy, atrial fibrillation or any significant cardiac arrhythmia)
- •History of cerebrovascular disease
- •History of orthostatic hypotension.
- •History of syncope.
- •History of allergy of adverse effects to study medications or drugs of the same pharmacologic classes.
研究组 & 干预措施
Diuretic
Active Comparator
Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM
干预措施: Hydrochlorothiazide (Drug)
Calcium-channel blocker
Active Comparator
Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
干预措施: Amlodipine (Drug)
Angiotensin Receptor Blocker
Active Comparator
Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
干预措施: Telmisartan (Drug)
结局指标
主要结局
Change is 24-hour Systolic Blood Pressure From Baseline to 4 Weeks
时间窗: 4 weeks
次要结局
- Change in 24-hour Diastolic Blood Pressure From Baseline to 4 Weeks(4 weeks)
- Change in 24-hour Mean Arterial Pressure From Baseline to 4 Weeks(4 weeks)
- Change in 24 Hour Pulse Pressure From Baseline to 4 Weeks(4 weeks)
- Change in Central (Aortic) Pulse Pressure, Carotid Arterial, From Baseline to 4 Weeks(4 weeks)
- Change in Carotid-femoral Pulse Wave Velocity From Baseline to 4 Weeks(4 weeks)
研究者
Josefina Medina-Lezama, MD
Principal Investigator
Prevencion
研究点 (1)
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