HIGH Altitude CArdiovascular REsearch Latin America Population Study

Completed

• Conditions: Hypertension; Altitude Sickness; Sleep; Altitude Hypoxia; Erythrocytosis; Cardiovascular Risk Factor
• Interventions: Other: Exposure to high altitude

• Registration Number: NCT04751292
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-26
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-12
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 937

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Highlanders	Exposure to high altitude	People living at high (\>2500 m) altitude

Primary Outcome Measures

Name	Time	Method
Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.	baseline

Secondary Outcome Measures

Name	Time	Method
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	self reported sleep duration (hours)
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	Pittsburgh questionnaire (score)
Difference in estimated cardiovascular risk	baseline
Difference between lowlanders and highlanders in hypertension prevalence	baseline

Trial Locations

Locations (1)

Universidad Peruana Cayetano Heredia; 🇵🇪 Lima, Peru