Skip to content

HIGH Altitude CArdiovascular REsearch Latin America Population Study

HIGH Altitude CArdiovascular REsearch Latin America Population Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04751292
Acronym
HIGHCARE-LAPS
Enrollment
937
Registered
2021-02-12
Start date
2021-01-26
Completion date
2023-12-30
Last updated
2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Altitude Hypoxia, Altitude Sickness, Cardiovascular Risk Factor, Erythrocytosis, Hypertension, Sleep

Keywords

ambulatory blood pressure monitoring, echocardiography

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.

Interventions

permanence at high (\>2500 m) altitude; permanence is defined as being born and living at high altitude with the total time spent at lower altitudes not exceeding 2 years in the past 10 years

Sponsors

Universidad Peruana Cayetano Heredia
CollaboratorOTHER
University of Milano Bicocca
CollaboratorOTHER
Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Difference in sleep quality between lowlanders and highlandersbaselinePittsburgh questionnaire (score)
Difference in estimated cardiovascular riskbaseline
Difference between lowlanders and highlanders in hypertension prevalencebaseline
Difference in a number of BP variables between highlanders living at three high altitude levelsbaseline
Differences in 24 h DBP, daytime and night-time systolic and diastolic BP between lowlanders and highlandersbaseline
Difference in conventional systolic and diastolic BP between lowlanders and highlandersbaseline
Difference in home systolic and diastolic BP between lowlanders and highlandersbaseline
Difference in sleep duration between lowlanders and highlandersbaselineself reported sleep duration (hours)

Other

MeasureTime frameDescription
Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Apnea Hypopnea Index during sleepbaselineCardiorespiratory sleep monitoring
Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in nocturnal oxygen saturationbaselineCardiorespiratory sleep monitoring
Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Left Ventricular Mass assessed by echocardiographybaselineechocardiography, ASE convention

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026