Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-04-05 @ 1:44 AM
Study NCT ID:
NCT03165656
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Right Ventricular Function at Rest in Highlanders/Lowlanders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535833', 'term': 'Pulmonary edema of mountaineers'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-15', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary artery pressure', 'timeFrame': 'Day 2', 'description': 'Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in tricuspid pressure gradient, measured by transthoracic echocardiography'}], 'secondaryOutcomes': [{'measure': 'cardiac output', 'timeFrame': 'Day 2', 'description': 'Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in cardiac output, measured by transthoracic echocardiography'}, {'measure': 'right heart dimensions', 'timeFrame': 'Day 2', 'description': 'Difference of right heart dimensions between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography'}, {'measure': 'Right heart function', 'timeFrame': 'Day 2', 'description': 'Differences of right heart function between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography (TAPSE)'}, {'measure': 'stroke volume', 'timeFrame': 'Day 2', 'description': 'Difference between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders in stroke volume, measured by transthoracic echocardiography'}, {'measure': 'volumes', 'timeFrame': 'Day 2', 'description': 'Difference of volumes between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Echocardiography', 'right ventricular function', 'pulmonary hypertension', 'disease progression', 'hypoxia'], 'conditions': ['High Altitude Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '32430415', 'type': 'DERIVED', 'citation': 'Gosens R, Hiemstra PS, Adcock IM, Bracke KR, Dickson RP, Hansbro PM, Krauss-Etschmann S, Smits HH, Stassen FRM, Bartel S. Host-microbe cross-talk in the lung microenvironment: implications for understanding and treating chronic lung disease. Eur Respir J. 2020 Aug 20;56(2):1902320. doi: 10.1183/13993003.02320-2019. Print 2020 Aug.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to evaluate the progression of right ventricular function and dimension in Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a cross sectional case-control study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Highlanders with high altitude pulmonary hypertension living at an altitude of 2500-4000 m; healthy highlanders living at an altitude of 2500-4000 m; healthy lowlanders living at an altitude of \\<1000 m.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high altitude pulmonary hypertension confirmed by clinical presentation and mean pulmonary artery pressure \\>30 mmHg measured by echocardiography at altitude of residence.\n* healthy subjects (high altitude controls)\n* Both genders\n* Age \\>16 y\n* Kyrgyz ethnicity\n* born, raised and currently living at \\>2500 m\n* healthy subjects currently living at \\<1000 m (low altitude controls)\n\nExclusion Criteria:\n\n* Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography\n* Excessive erythrocytosis\n* Other coexistent disorders that may interfere with the cardio-respiratory system and sleep\n* Regular use of medication that affects control of breathing\n* Heavy smoking'}, 'identificationModule': {'nctId': 'NCT03165656', 'briefTitle': 'Right Ventricular Function at Rest in Highlanders/Lowlanders', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Right Ventricular Function at Rest in Highlanders With Pulmonary Hypertension Compared to Highlanders Without Pulmonary Hypertension and Lowlanders', 'orgStudyIdInfo': {'id': '01-8/433A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High altitude pulmonary hypertension', 'description': 'Highlanders with high altitude pulmonary hypertension living above 2500 m.'}, {'label': 'High altitude control', 'description': 'Healthy highlanders living above 2500 m.'}, {'label': 'Low altitude control', 'description': 'Healthy lowlanders living below 1000 m.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '720040', 'city': 'Bishkek', 'country': 'Kyrgyzstan', 'facility': 'National Center for Cardiology and Internal Medicine', 'geoPoint': {'lat': 42.87, 'lon': 74.59}}], 'overallOfficials': [{'name': 'Talant M Sooronbaev, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Silvia Ulrich Somaini', 'investigatorAffiliation': 'University of Zurich'}}}}