HIGH Altitude CArdiovascular REsearch in the ANDES
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude
研究概览
简要总结
This study is aimed to assess the efficacy of combined treatment with two antihypertensive agents (telmisartan and nifedipine) in subjects with mild hypertension exposed to high altitude.
详细描述
This is a parallel group, prospective, double-blind, placebo controlled randomized trial, comparing the effects of combination of two antihypertensive agents (telmisartan/nifedipine)with placebo in hypertensive subjects exposed to high altitude. The principal objectives are:
- to assess the response of BP to high altitude exposure in hypertensive subjects residing at sea level
- To assess the efficacy and safety of combination of telmisartan 80 mg with nifedipine GITS 30 mg in preventing a possible excessive BP increase in hypertensive subjects exposed to high altitude.
The following data will be collected during the study at the different steps:
- Clinical history
- Symptoms and adverse events questionnaire
- Conventional BP and heart rate (HR) measurement - seated measurements with a validated oscillometric device will be performed after at least 5 minutes rest on non-dominant arm; two measurements will be performed 1-2 minutes apart and their average will be used in the analyses
- Vital signs:
respiratory rate - will be measured manually over 60 seconds body height and weight, waist circumference blood oxygen saturation (SpO2)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanent residence at low (<500 m) altitude
- •Conventional systolic BP (average of two measurements) 140-159 mmHg or conventional diastolic BP 90-99 mmHg in subjects untreated or after 4 weeks of washout
- •Mean daytime systolic BP ≥135 and <150 mmHg and/or mean daytime diastolic BP ≥85 and <95 mmHg in subjects untreated or after 4 weeks of washout
- •Written informed consent to participate in the study
排除标准
- •Conventional systolic BP (average of two measurements) ≥150 mmHg and conventional diastolic BP ≥95 mmHg in treated subjects
- •Regular use of two or more antihypertensive drugs (with the exception of subjects on two antihypertensive drugs in low doses)
- •Treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously used antihypertensive agent)
- •Contraindications (including a history of adverse reactions) to angiotensin receptor blockers or calcium antagonists
- •History of serious mountain sickness
- •Subjects who over 3 months preceding inclusion in the study spent considerable (> 1 week) amount of time at altitudes above 2500 m.
- •Cardiovascular diseases other than hypertension (coronary heart disease, heart failure, atrial fibrillation, valvular or congenital heart disease, cardiomyopathies, cerebrovascular disease, peripheral artery disease, aortic aneurysm)
- •Suspected or confirmed secondary hypertension
- •Diabetes mellitus
- •Serious respiratory disorders
- •Other conditions deemed relevant by the investigator (including liver disease, renal disease, thyroid disorders)
- •BMI ≥35 kg/m2
- •Upper arm circumference >32 cm
- •known severe obstructive sleep apnea (apnea-hypopnea index > 30 or use of CPAP) or excessive daytime sleepiness (Epworth Sleepiness Scale > 10)
- •Pregnancy
- •Premenopausal women not using effective contraceptive methods
- •Elevated probability of noncompliance with the study procedures
研究组 & 干预措施
Telmisartan/nifedipine
Subjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination
干预措施: Telmisartan (Drug)
Telmisartan/nifedipine
Subjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination
干预措施: Nifedipine (Drug)
Placebo
Two tablets containing placebo daily in the morning
干预措施: placebo (Drug)
结局指标
主要结局
Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude
时间窗: After 6 weeks of study treatment, during high altitude visit
Difference in 24 h ambulatory systolic BP at high altitude (Visit 4) between combination therapy group and placebo group
次要结局
- Effect of study treatment on ambulatory blood pressure at high altitude (other variables)(After 6 weeks of study treatment, during high altitude visit)
- Lake Louise Score(After 6 weeks of study treatment, during high altitude visit)
- Effect of high altitude on ambulatory blood pressure(After 6 weeks of study treatment, during high altitude visit)
- Effect of high altitude on conventional blood pressure(After 6 weeks of study treatment, during high altitude visit)
- Effect of study treatment on conventional blood pressure at high altitude.(After 6 weeks of study treatment, during high altitude visit)
- Rate of adverse events(After 6 weeks of treatment plus up to 1 additional week of treatment needed for high altitude visit (study end).)
- Effect of study treatment on ambulatory heart rate at high altitude(After 6 weeks of study treatment, during high altitude visit)