Clinical trial NCT04751292: HIGH Altitude CArdiovascular REsearch Latin America Population Study
Official title: HIGH Altitude CArdiovascular REsearch Latin America Population Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Cardiovascular Risk Factor
Altitude Hypoxia
Altitude Sickness
Erythrocytosis
Sleep
Keywords: ambulatory blood pressure monitoring
echocardiography
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Universidad Peruana Cayetano Heredia
name: University of Milano Bicocca
First posted: 2021-02-12
Enrollment: 937
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.
timeFrame: baseline
Secondary outcomes:
measure: Differences in 24 h DBP, daytime and night-time systolic and diastolic BP between lowlanders and highlanders
timeFrame: baseline
measure: Difference in conventional systolic and diastolic BP between lowlanders and highlanders
timeFrame: baseline
measure: Difference in home systolic and diastolic BP between lowlanders and highlanders
timeFrame: baseline
measure: Difference in sleep quality between lowlanders and highlanders
timeFrame: baseline
measure: Difference in sleep duration between lowlanders and highlanders
timeFrame: baseline
measure: Difference in estimated cardiovascular risk
timeFrame: baseline
measure: Difference between lowlanders and highlanders in hypertension prevalence
timeFrame: baseline
measure: Difference in a number of BP variables between highlanders living at three high altitude levels
timeFrame: baseline
Other outcomes:
measure: Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Left Ventricular Mass assessed by echocardiography
timeFrame: baseline
measure: Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in nocturnal oxygen saturation
timeFrame: baseline
measure: Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Apnea Hypopnea Index during sleep
timeFrame: baseline
Locations:
city: Lima
country: Peru
facility: Universidad Peruana Cayetano Heredia
Study officials:
affiliation: Istituto Auxologico Italiano
name: Gianfranco Parati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Auxologico Italiano
name: Grzegorz Bilo, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Peruviana Cayetano Heredia
name: Francisco Villafuerte, PhD
role: STUDY_DIRECTOR
References:
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