Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
Study NCT ID:
NCT04751292
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2021-02-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HIGH Altitude CArdiovascular REsearch Latin America Population Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000532', 'term': 'Altitude Sickness'}, {'id': 'D011086', 'term': 'Polycythemia'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 937}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Left Ventricular Mass assessed by echocardiography', 'timeFrame': 'baseline', 'description': 'echocardiography, ASE convention'}, {'measure': 'Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in nocturnal oxygen saturation', 'timeFrame': 'baseline', 'description': 'Cardiorespiratory sleep monitoring'}, {'measure': 'Differences between lowlanders and highlanders and among highlanders living at different high altitude levels in Apnea Hypopnea Index during sleep', 'timeFrame': 'baseline', 'description': 'Cardiorespiratory sleep monitoring'}], 'primaryOutcomes': [{'measure': 'Difference in 24 h ambulatory systolic BP between lowlanders and highlanders.', 'timeFrame': 'baseline'}], 'secondaryOutcomes': [{'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', 'description': 'Pittsburgh questionnaire (score)'}, {'measure': 'Difference in sleep duration between lowlanders and highlanders', 'timeFrame': 'baseline', 'description': 'self reported sleep duration (hours)'}, {'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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ambulatory blood pressure monitoring', 'echocardiography'], 'conditions': ['Hypertension', 'Cardiovascular Risk Factor', 'Altitude Hypoxia', 'Altitude Sickness', 'Erythrocytosis', 'Sleep']}, 'referencesModule': {'references': [{'pmid': '33175629', 'type': 'BACKGROUND', '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.'}, {'pmid': '31780104', 'type': 'BACKGROUND', '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.'}, {'pmid': '31099758', 'type': 'BACKGROUND', '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.'}, {'pmid': '17597013', 'type': 'BACKGROUND', '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.'}, {'pmid': '29340578', 'type': 'BACKGROUND', '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.'}, {'pmid': '10190881', 'type': 'BACKGROUND', '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.'}, {'pmid': '12563015', 'type': 'BACKGROUND', '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.'}, {'pmid': '17984389', 'type': 'BACKGROUND', '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.'}, {'pmid': '20102863', 'type': 'BACKGROUND', '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.'}, {'pmid': '21045724', 'type': 'BACKGROUND', '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.'}, {'pmid': '25161182', 'type': 'BACKGROUND', '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.'}, {'pmid': '25895588', 'type': 'BACKGROUND', '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.'}, {'pmid': '29939783', 'type': 'BACKGROUND', '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.'}, {'pmid': '27575245', 'type': 'BACKGROUND', 'citation': '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': '21672719', 'type': 'BACKGROUND', '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.'}, {'pmid': '28115473', 'type': 'BACKGROUND', '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.'}, {'pmid': '30165516', 'type': 'BACKGROUND', '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.'}, {'pmid': '29146535', 'type': 'BACKGROUND', '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.'}, {'pmid': '24029863', 'type': 'BACKGROUND', '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."}, {'pmid': '29782186', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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).\n\nOn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will be recruited by random sampling from the general population residing permanently in urban areas at:\n\n1. Sea level (lowlanders): \\<500m altitude (the city of Lima and surroundings, population 7.605.742)\n2. High altitude (highlanders):\n\n * 2500-3500 m (Cajamarca, 2,720 m, population 283.767; Cuzco, 3,399 m, pop. 420.137; Huancayo, 3.287m, pop. 501.384)\n * 3500-4000 m Juliaca, 3,824 m, pop. 216.716,\n * \\>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)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>18 years) male and female subjects;\n* Highlanders: permanence at high (\\>2500 m) altitude;\n* Lowlanders: permanence at low (\\<1500 m) altitude;\n* Written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Lowlanders who over 3 months preceding inclusion in the study spent considerable (\\> 7 consecutive days) amount of time at altitudes above 1500 m;\n* Highlanders who over 3 months preceding inclusion in the study spent considerable (\\>7 consecutive days) amount of time at altitudes below 2500 m;\n* Subjects cognitively incapable of providing informed consent or responding to a questionnaire\n* Physical disability that would prevent study assessments from being performed\n* Active pulmonary tuberculosis\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04751292', 'acronym': 'HIGHCARE-LAPS', 'briefTitle': 'HIGH Altitude CArdiovascular REsearch Latin America Population Study', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'HIGH Altitude CArdiovascular REsearch Latin America Population Study', 'orgStudyIdInfo': {'id': '09A921'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lowlanders', 'description': 'People living at low (\\<1500 m) altitude'}, {'label': 'Highlanders', 'description': 'People living at high (\\>2500 m) altitude', 'interventionNames': ['Other: Exposure to high altitude']}], 'interventions': [{'name': 'Exposure to high altitude', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Highlanders']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lima', 'country': 'Peru', 'facility': 'Universidad Peruana Cayetano Heredia', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}], 'overallOfficials': [{'name': 'Gianfranco Parati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Auxologico Italiano'}, {'name': 'Grzegorz Bilo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istituto Auxologico Italiano'}, {'name': 'Francisco Villafuerte, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Peruviana Cayetano Heredia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The data will be placed in a public repository and available upon reasonable request after study completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Peruana Cayetano Heredia', 'class': 'OTHER'}, {'name': 'University of Milano Bicocca', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}