HIGH Altitude CArdiovascular REsearch Latin America Population Study

NCT04751292 | Completed

• 1 other identifier: 09A921
• Study Type: observational
• Target: 937
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Cardiovascular Risk Factor; Altitude Hypoxia; Altitude Sickness; Erythrocytosis; Sleep

Keywords

ambulatory blood pressure monitoring; echocardiography

Outcome Measures

Primary Outcomes (1)

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

  baseline

Secondary Outcomes (8)

• 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

• Difference in sleep duration between lowlanders and highlanders

  baseline

Other Outcomes (3)

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

  baseline

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

  baseline

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

  baseline

Study Arms (2)

Lowlanders

People living at low (\<1500 m) altitude

Highlanders

People living at high (\>2500 m) altitude

Other: Exposure to high altitude

Interventions

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

Highlanders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Universidad Peruana Cayetano Heredia: collaborator
• University of Milano Bicocca: collaborator

Study Sites (1)

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Related Publications (20)

• Bilo G, Acone L, Anza-Ramirez C, Macarlupu JL, Soranna D, Zambon A, Vizcardo-Galindo G, Pengo MF, Villafuerte FC, Parati G; HIGHCARE-ANDES Highlanders Study Investigators. Office and Ambulatory Arterial Hypertension in Highlanders: HIGHCARE-ANDES Highlanders Study. Hypertension. 2020 Dec;76(6):1962-1970. doi: 10.1161/HYPERTENSIONAHA.120.16010. Epub 2020 Nov 11.

  PMID: 33175629 BACKGROUND

• Torlasco C, Bilo G, Giuliano A, Soranna D, Ravaro S, Oliverio G, Faini A, Zambon A, Lombardi C, Parati G. Effects of acute exposure to moderate altitude on blood pressure and sleep breathing patterns. Int J Cardiol. 2020 Feb 15;301:173-179. doi: 10.1016/j.ijcard.2019.09.034. Epub 2019 Oct 30.

  PMID: 31780104 BACKGROUND

• Bilo G, Caravita S, Torlasco C, Parati G. Blood pressure at high altitude: physiology and clinical implications. Kardiol Pol. 2019 Jun 25;77(6):596-603. doi: 10.33963/KP.14832. Epub 2019 May 17.

  PMID: 31099758 BACKGROUND

• Hainsworth R, Drinkhill MJ. Cardiovascular adjustments for life at high altitude. Respir Physiol Neurobiol. 2007 Sep 30;158(2-3):204-11. doi: 10.1016/j.resp.2007.05.006. Epub 2007 May 18.

  PMID: 17597013 BACKGROUND

• Parati G, Agostoni P, Basnyat B, Bilo G, Brugger H, Coca A, Festi L, Giardini G, Lironcurti A, Luks AM, Maggiorini M, Modesti PA, Swenson ER, Williams B, Bartsch P, Torlasco C. Clinical recommendations for high altitude exposure of individuals with pre-existing cardiovascular conditions: A joint statement by the European Society of Cardiology, the Council on Hypertension of the European Society of Cardiology, the European Society of Hypertension, the International Society of Mountain Medicine, the Italian Society of Hypertension and the Italian Society of Mountain Medicine. Eur Heart J. 2018 May 1;39(17):1546-1554. doi: 10.1093/eurheartj/ehx720.

  PMID: 29340578 BACKGROUND

• Duplain H, Vollenweider L, Delabays A, Nicod P, Bartsch P, Scherrer U. Augmented sympathetic activation during short-term hypoxia and high-altitude exposure in subjects susceptible to high-altitude pulmonary edema. Circulation. 1999 Apr 6;99(13):1713-8. doi: 10.1161/01.cir.99.13.1713.

  PMID: 10190881 BACKGROUND

• Hansen J, Sander M. Sympathetic neural overactivity in healthy humans after prolonged exposure to hypobaric hypoxia. J Physiol. 2003 Feb 1;546(Pt 3):921-9. doi: 10.1113/jphysiol.2002.031765.

  PMID: 12563015 BACKGROUND

• Bartsch P, Gibbs JS. Effect of altitude on the heart and the lungs. Circulation. 2007 Nov 6;116(19):2191-202. doi: 10.1161/CIRCULATIONAHA.106.650796. No abstract available.

  PMID: 17984389 BACKGROUND

• Higgins JP, Tuttle T, Higgins JA. Altitude and the heart: is going high safe for your cardiac patient? Am Heart J. 2010 Jan;159(1):25-32. doi: 10.1016/j.ahj.2009.10.028.

  PMID: 20102863 BACKGROUND

• Bilo G, Caldara G, Styczkiewicz K, Revera M, Lombardi C, Giglio A, Zambon A, Corrao G, Faini A, Valentini M, Mancia G, Parati G. Effects of selective and nonselective beta-blockade on 24-h ambulatory blood pressure under hypobaric hypoxia at altitude. J Hypertens. 2011 Feb;29(2):380-7. doi: 10.1097/HJH.0b013e3283409014.

  PMID: 21045724 BACKGROUND

• Parati G, Bilo G, Faini A, Bilo B, Revera M, Giuliano A, Lombardi C, Caldara G, Gregorini F, Styczkiewicz K, Zambon A, Piperno A, Modesti PA, Agostoni P, Mancia G. Changes in 24 h ambulatory blood pressure and effects of angiotensin II receptor blockade during acute and prolonged high-altitude exposure: a randomized clinical trial. Eur Heart J. 2014 Nov 21;35(44):3113-22. doi: 10.1093/eurheartj/ehu275. Epub 2014 Aug 26.

  PMID: 25161182 BACKGROUND

• Bilo G, Villafuerte FC, Faini A, Anza-Ramirez C, Revera M, Giuliano A, Caravita S, Gregorini F, Lombardi C, Salvioni E, Macarlupu JL, Ossoli D, Landaveri L, Lang M, Agostoni P, Sosa JM, Mancia G, Parati G. Ambulatory blood pressure in untreated and treated hypertensive patients at high altitude: the High Altitude Cardiovascular Research-Andes study. Hypertension. 2015 Jun;65(6):1266-72. doi: 10.1161/HYPERTENSIONAHA.114.05003. Epub 2015 Apr 20.

  PMID: 25895588 BACKGROUND

• Savla JJ, Levine BD, Sadek HA. The Effect of Hypoxia on Cardiovascular Disease: Friend or Foe? High Alt Med Biol. 2018 Jun;19(2):124-130. doi: 10.1089/ham.2018.0044.

  PMID: 29939783 BACKGROUND

• Aryal N, Weatherall M, Bhatta YK, Mann S. Blood Pressure and Hypertension in Adults Permanently Living at High Altitude: A Systematic Review and Meta-Analysis. High Alt Med Biol. 2016 Sep;17(3):185-193. doi: 10.1089/ham.2015.0118. Epub 2016 Aug 30.

  PMID: 27575245 BACKGROUND

• Beall CM. Andean, Tibetan, and Ethiopian patterns of adaptation to high-altitude hypoxia. Integr Comp Biol. 2006 Feb;46(1):18-24. doi: 10.1093/icb/icj004. Epub 2006 Jan 6.

  PMID: 21672719 BACKGROUND

• Bernabe-Ortiz A, Carrillo-Larco RM, Gilman RH, Checkley W, Smeeth L, Miranda JJ; CRONICAS Cohort Study Group. Impact of urbanisation and altitude on the incidence of, and risk factors for, hypertension. Heart. 2017 Jun;103(11):827-833. doi: 10.1136/heartjnl-2016-310347. Epub 2017 Jan 23.

  PMID: 28115473 BACKGROUND

• Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.

  PMID: 30165516 BACKGROUND

• Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available.

  PMID: 29146535 BACKGROUND

• O'Brien E, Parati G, Stergiou G, Asmar R, Beilin L, Bilo G, Clement D, de la Sierra A, de Leeuw P, Dolan E, Fagard R, Graves J, Head GA, Imai Y, Kario K, Lurbe E, Mallion JM, Mancia G, Mengden T, Myers M, Ogedegbe G, Ohkubo T, Omboni S, Palatini P, Redon J, Ruilope LM, Shennan A, Staessen JA, vanMontfrans G, Verdecchia P, Waeber B, Wang J, Zanchetti A, Zhang Y; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension position paper on ambulatory blood pressure monitoring. J Hypertens. 2013 Sep;31(9):1731-68. doi: 10.1097/HJH.0b013e328363e964.

  PMID: 24029863 BACKGROUND

• Corante N, Anza-Ramirez C, Figueroa-Mujica R, Macarlupu JL, Vizcardo-Galindo G, Bilo G, Parati G, Gamboa JL, Leon-Velarde F, Villafuerte FC. Excessive Erythrocytosis and Cardiovascular Risk in Andean Highlanders. High Alt Med Biol. 2018 Sep;19(3):221-231. doi: 10.1089/ham.2017.0123. Epub 2018 May 21.

  PMID: 29782186 BACKGROUND

MeSH Terms

Conditions

Hypertension; Altitude Sickness; Polycythemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Gianfranco Parati, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

• Grzegorz Bilo, PhD

  Istituto Auxologico Italiano

  STUDY DIRECTOR

• Francisco Villafuerte, PhD

  Universidad Peruviana Cayetano Heredia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 12, 2021
• Study Start: January 26, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

PE (1)