HIGH Altitude CArdiovascular REsearch Latin America Population Study

Hypertension Clinical Trial

— HIGHCARE-LAPS  

Official title:

HIGH Altitude CArdiovascular REsearch Latin America Population Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751292
• Other study ID #: 09A921
• Status: Completed
• Start date: January 26, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2024
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 937
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Altitude Hypoxia
• Altitude Sickness
• Cardiovascular Risk Factor
• Erythrocytosis
• Hypertension
• Hypoxia
• Polycythemia
• Sleep

Intervention

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

Locations

Country	Name	City	State
Peru	Universidad Peruana Cayetano Heredia	Lima

Sponsors (3)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	Universidad Peruana Cayetano Heredia, University of Milano Bicocca

Country where clinical trial is conducted

Peru, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Hypertens. 2013 Dec;31(12):2467. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Am Coll Cardiol. 2018 May 15;71(19):2275-2279. — View Citation

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. Erratum In: Eur Heart J. 2019 Feb 1;40(5):475. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Left Ventricular Mass assessed by echocardiography	echocardiography, ASE convention	baseline
Other	Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in nocturnal oxygen saturation	Cardiorespiratory sleep monitoring	baseline
Other	Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Apnea Hypopnea Index during sleep	Cardiorespiratory sleep monitoring	baseline
Primary	Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.		baseline
Secondary	Differences in 24 h DBP, daytime and night-time systolic and diastolic BP between lowlanders and highlanders		baseline
Secondary	Difference in conventional systolic and diastolic BP between lowlanders and highlanders		baseline
Secondary	Difference in home systolic and diastolic BP between lowlanders and highlanders		baseline
Secondary	Difference in sleep quality between lowlanders and highlanders	Pittsburgh questionnaire (score)	baseline
Secondary	Difference in sleep duration between lowlanders and highlanders	self reported sleep duration (hours)	baseline
Secondary	Difference in estimated cardiovascular risk		baseline
Secondary	Difference between lowlanders and highlanders in hypertension prevalence		baseline
Secondary	Difference in a number of BP variables between highlanders living at three high altitude levels		baseline