An observational study in Hypertension, Cardiovascular Risk Factor and Altitude Hypoxia, sponsored by Istituto Auxologico Italiano. Completed at 1 site in Peru. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Istituto Auxologico Italiano · Observational
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 937 is above the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study participants will be recruited by random sampling from the general population residing permanently in urban areas at:
High altitude (highlanders):
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People living at low (\<1500 m) altitude
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
Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.
Time frame: baseline
Differences in 24 h DBP, daytime and night-time systolic and diastolic BP between lowlanders and highlanders
Time frame: baseline
Difference in conventional systolic and diastolic BP between lowlanders and highlanders
Time frame: baseline
Difference in home systolic and diastolic BP between lowlanders and highlanders
Time frame: baseline
Difference in sleep quality between lowlanders and highlanders
Pittsburgh questionnaire (score)
Time frame: baseline
Difference in sleep duration between lowlanders and highlanders
self reported sleep duration (hours)
Time frame: baseline
Difference in estimated cardiovascular risk
Time frame: baseline
Difference between lowlanders and highlanders in hypertension prevalence
Time frame: baseline
Difference in a number of BP variables between highlanders living at three high altitude levels
Time frame: baseline
Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Left Ventricular Mass assessed by echocardiography
echocardiography, ASE convention
Time frame: baseline
Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in nocturnal oxygen saturation
Cardiorespiratory sleep monitoring
Time frame: baseline
Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Apnea Hypopnea Index during sleep
Cardiorespiratory sleep monitoring
Time frame: baseline
Plan to share: Yes — The data will be placed in a public repository and available upon reasonable request after study completion
Ran from Jan 2021 to primary completion in Dec 2023, 35 months.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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