HIGHCARE-LAPS: HIGH Altitude CArdiovascular REsearch Latin America Population Study

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Recruiting

CT.gov ID

NCT04751292

Collaborator

Universidad Peruana Cayetano Heredia (Other), University of Milano Bicocca (Other)

900

Enrollment

Location

22.1

Anticipated Duration (Months)

40.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Cardiovascular Risk Factor Altitude Hypoxia Altitude Sickness Erythrocytosis Sleep	Other: Exposure to high altitude

Study Design

Study Type:

Observational

Anticipated Enrollment :

900 participants

Observational Model:

Ecologic or Community

Time Perspective:

Cross-Sectional

Official Title:

HIGH Altitude CArdiovascular REsearch Latin America Population Study

Actual Study Start Date :

Jan 26, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Difference in 24 h ambulatory systolic BP between lowlanders and highlanders. [baseline]

Secondary Outcome Measures

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

Other Outcome Measures

Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Left Ventricular Mass assessed by echocardiography [baseline]
echocardiography, ASE convention
Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in nocturnal oxygen saturation [baseline]
Cardiorespiratory sleep monitoring
Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Apnea Hypopnea Index during sleep [baseline]
Cardiorespiratory sleep monitoring

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Peruana Cayetano Heredia	Lima		Peru

Sponsors and Collaborators

Istituto Auxologico Italiano
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