Brief Title
HIGH Altitude CArdiovascular REsearch Latin America Population Study
Official Title
HIGH Altitude CArdiovascular REsearch Latin America Population Study
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.
Study Type
Observational
Primary Outcome
Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.
Secondary Outcome
Differences in 24 h DBP, daytime and night-time systolic and diastolic BP between lowlanders and highlanders
Condition
Hypertension
Intervention
Exposure to high altitude
Study Arms / Comparison Groups
Lowlanders
Description: People living at low (<1500 m) altitude
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
900
Start Date
February 2021
Completion Date
December 2022
Primary Completion Date
August 2022
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Gianfranco Parati, MD, +39 02 619112714, [email protected]
Administrative Informations
NCT ID
NCT04751292
Organization ID
09A921
Responsible Party
Sponsor
Study Sponsor
Istituto Auxologico Italiano
Collaborators
Universidad Peruana Cayetano Heredia
Study Sponsor
Gianfranco Parati, MD, Principal Investigator, Istituto Auxologico Italiano
Verification Date
February 2021