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临床试验/NCT04751292
NCT04751292已完成不适用

HIGH Altitude CArdiovascular REsearch Latin America Population Study

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 937 人开始时间: 2021年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
937
试验地点
1
主要终点
Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.

研究概览

简要总结

High blood pressure (BP) is one of the principal cardiovascular risk factors. While BP levels and hypertension prevalence are well characterized in many populations, information on BP and on cardiovascular risk profile in high altitude inhabitants is limited and frequently contradictory, especially in the large highland populations of South America. The information on the effects of permanent high altitude exposure on cardiovascular variables including BP may be relevant in the light of the known BP-increasing effect of acute exposure to high altitude hypoxia. This information may have practical implications for millions of people living at elevated altitudes in Asia, South America and Africa.

The inconclusive epidemiological evidence on BP and cardiovascular risk in high altitude dwellers may be the result of several factors, among them: 1) confounding by genetic and socio-economic factors; 2) imperfect methods of BP evaluation, in particular lack of data on ambulatory and home BP (both methods considered superior to conventional clinic BP in the assessment of exposure to high BP).

On this background, the general aim of the study is to compare blood pressure levels and cardiovascular risk profile among population-based samples of subjects residing in Peruvian communities living at different altitudes.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (>18 years) male and female subjects;
  • Highlanders: permanence at high (>2500 m) altitude;
  • Lowlanders: permanence at low (<1500 m) altitude;
  • Written informed consent to participate in the study

排除标准

  • Lowlanders who over 3 months preceding inclusion in the study spent considerable (> 7 consecutive days) amount of time at altitudes above 1500 m;
  • Highlanders who over 3 months preceding inclusion in the study spent considerable (>7 consecutive days) amount of time at altitudes below 2500 m;
  • Subjects cognitively incapable of providing informed consent or responding to a questionnaire
  • Physical disability that would prevent study assessments from being performed
  • Active pulmonary tuberculosis
  • Pregnancy

结局指标

主要结局

Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.

时间窗: baseline

次要结局

  • Difference in home systolic and diastolic BP between lowlanders and highlanders(baseline)
  • Differences in 24 h DBP, daytime and night-time systolic and diastolic BP between lowlanders and highlanders(baseline)
  • Difference in conventional systolic and diastolic BP between lowlanders and highlanders(baseline)
  • Difference in sleep duration between lowlanders and highlanders(baseline)
  • Difference in a number of BP variables between highlanders living at three high altitude levels(baseline)
  • Difference in sleep quality between lowlanders and highlanders(baseline)
  • Difference in estimated cardiovascular risk(baseline)
  • Difference between lowlanders and highlanders in hypertension prevalence(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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