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HIGH Altitude CArdiovascular REsearch Latin America Population Study (HIGHCARE-LAPS)

I

Istituto Auxologico Italiano

Status

Completed

Conditions

Altitude Sickness
Altitude Hypoxia
Hypertension
Erythrocytosis
Cardiovascular Risk Factor
Sleep

Treatments

Other: Exposure to high altitude

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

937 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

937 participants in 2 patient groups

Lowlanders
Description:
People living at low (\<1500 m) altitude
Highlanders
Description:
People living at high (\>2500 m) altitude
Treatment:
Other: Exposure to high altitude

Trial contacts and locations

1

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Central trial contact

Lucia Zanotti, PhD; Grzegorz Bilo, PhD

Data sourced from clinicaltrials.gov

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