HIGH Altitude CArdiovascular REsearch Latin America Population Study

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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