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Completed

NCT Number: NCT04751292

HIGH Altitude CArdiovascular REsearch Latin America Population Study

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.

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Key information

Conditions

Hypertension Altitude Hypoxia Altitude Sickness Cardiovascular Diseases Cardiovascular Risk Factor Erythrocytosis Hematologic Diseases Hemic and Lymphatic Diseases Polycythemia Respiration Disorders Respiratory Tract Diseases Sleep Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad Peruana Cayetano Heredia

Lima, Peru

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure to high altitude

Other

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

Primary outcomes

  1. Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.

    Time frame: baseline

Secondary outcomes

  1. Differences in 24 h DBP, daytime and night-time systolic and diastolic BP between lowlanders and highlanders

    Time frame: baseline

  2. Difference in conventional systolic and diastolic BP between lowlanders and highlanders

    Time frame: baseline

  3. Difference in home systolic and diastolic BP between lowlanders and highlanders

    Time frame: baseline

  4. Difference in sleep quality between lowlanders and highlanders

    Time frame: baseline

    Pittsburgh questionnaire (score)

  5. Difference in sleep duration between lowlanders and highlanders

    Time frame: baseline

    self reported sleep duration (hours)

  6. Difference in estimated cardiovascular risk

    Time frame: baseline

  7. Difference between lowlanders and highlanders in hypertension prevalence

    Time frame: baseline

  8. Difference in a number of BP variables between highlanders living at three high altitude levels

    Time frame: baseline

Other outcomes

  1. Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Left Ventricular Mass assessed by echocardiography

    Time frame: baseline

    echocardiography, ASE convention

  2. Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in nocturnal oxygen saturation

    Time frame: baseline

    Cardiorespiratory sleep monitoring

  3. Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Apnea Hypopnea Index during sleep

    Time frame: baseline

    Cardiorespiratory sleep monitoring

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • Universidad Peruana Cayetano Heredia
  • University of Milano Bicocca

Registry information

Acronym: HIGHCARE-LAPS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2021
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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