Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-02 @ 8:35 AM
Study NCT ID:
NCT03165032
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2017-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Right Ventricular Function During Exercise 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': 'D009043', 'term': 'Motor Activity'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, 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': '2017-05-22', 'studyFirstSubmitQcDate': '2017-05-22', '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 (PAP) during exercise', 'timeFrame': 'Day 2', 'description': 'Difference in change of tricuspid pressure gradient during exercise between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography during graded cycling on an ergometer'}], 'secondaryOutcomes': [{'measure': 'cardiac output (CO) during exercise', 'timeFrame': 'Day 2', 'description': 'Difference in change of cardiac output during exercise between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography during graded cycling on an ergometer'}, {'measure': 'PAP/CO slope during exercise', 'timeFrame': 'Day 2', 'description': 'Difference in change of PAP/CO slope during exercise between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography during graded cycling on an ergometer'}, {'measure': 'Oxygen saturation', 'timeFrame': 'Day 2', 'description': 'Difference in change of oxygen saturation during exercise between highlanders with pulmonary hypertension, healthy highlanders and healthy lowlanders, measured by transthoracic echocardiography during graded cycling on an ergometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'echocardiography', 'right ventricular function', 'pulmonary hypertension', 'hypoxia'], 'conditions': ['High Altitude Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to evaluate the right ventricular function during graded cycling on an ergometer by transthoracic echocardiography 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 pumonary 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': 'NCT03165032', 'briefTitle': 'Right Ventricular Function During Exercise in Highlanders/Lowlanders', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Right Ventricular Function During Exercise in Highlanders With Pulmonary Hypertension Compared to Highlanders Without Pulmonary Hypertension and Lowlanders', 'orgStudyIdInfo': {'id': '01-8/433B'}}, '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}}]}, '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'}}}}