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

February 29, 2024 updated by: Istituto Auxologico Italiano

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

937

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Peru
      • Lima, Peru
        • Universidad Peruana Cayetano Heredia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Study participants will be recruited by random sampling from the general population residing permanently in urban areas at:

  1. Sea level (lowlanders): <500m altitude (the city of Lima and surroundings, population 7.605.742)

  2. High altitude (highlanders):

    • 2500-3500 m (Cajamarca, 2,720 m, population 283.767; Cuzco, 3,399 m, pop. 420.137; Huancayo, 3.287m, pop. 501.384)
    • 3500-4000 m Juliaca, 3,824 m, pop. 216.716,
    • >4000 m (Ananea, 4.616m, pop. 20.572; La Rinconada 5.100m, pop. 50.000; Cerro de Pasco, 4.300-4.700 m, pop. 70.000)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lowlanders
People living at low (<1500 m) altitude
Highlanders
People living at high (>2500 m) altitude
Other: Exposure to high altitude
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in 24 h DBP, daytime and night-time systolic and diastolic BP between lowlanders and highlanders
Time Frame: baseline
baseline
Difference in conventional systolic and diastolic BP between lowlanders and highlanders
Time Frame: baseline
baseline
Difference in home systolic and diastolic BP between lowlanders and highlanders
Time Frame: baseline
baseline
Difference in sleep quality between lowlanders and highlanders
Time Frame: baseline
Pittsburgh questionnaire (score)
baseline
Difference in sleep duration between lowlanders and highlanders
Time Frame: baseline
self reported sleep duration (hours)
baseline
Difference in estimated cardiovascular risk
Time Frame: baseline
baseline
Difference between lowlanders and highlanders in hypertension prevalence
Time Frame: baseline
baseline
Difference in a number of BP variables between highlanders living at three high altitude levels
Time Frame: baseline
baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline
Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in nocturnal oxygen saturation
Time Frame: baseline
Cardiorespiratory sleep monitoring
baseline
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Collaborators

Universidad Peruana Cayetano Heredia
University of Milano Bicocca

Investigators

  • Principal Investigator: Gianfranco Parati, MD, Istituto Auxologico Italiano
  • Study Director: Grzegorz Bilo, PhD, Istituto Auxologico Italiano
  • Study Director: Francisco Villafuerte, PhD, Universidad Peruviana Cayetano Heredia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2021

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09A921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be placed in a public repository and available upon reasonable request after study completion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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