Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT03593005
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2018-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Exposure to High Altitude on Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000532', 'term': 'Altitude Sickness'}], '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': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Including a baseline assessment and assessments at Low altitude and High altitude'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-07-18', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Altitude related symptoms at High Altitude', 'timeFrame': '5 hours', 'description': 'Completion of altitude related questionnaires during the exposure to the Elevation of 2500m above sea level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Altitude', 'Altitude related symptoms'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) in altitude related symptoms', 'detailedDescription': 'Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.\n\nRandomly assigned to the order of testing, the participants will be tested at Low Altitude (Zurich, 470m) and High Altitude (2500m).\n\nRegularly during the exposure of approximately 5 hours, the participants will be asked to complete altitude related symptom questionnaires'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis\n* PH class 1 (PAH) or 4 (CTEPH)\n* Stable condition, on the same medication for \\> 4 weeks\n* Patient live permanently at an altitude \\< 1000m asl.\n\nExclusion Criteria:\n\n* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \\> 16hour daily (nocturnal oxygen therapy alone is allowed)\n* Severe daytime hypercapnia (pCO2 \\> 6.5 kPa)\n* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.\n* Exposure to an altitude \\>1500m for ≥3 nights during the last 4 weeks before the study participation\n* Residence \\> 1000m above sea level\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability\n* Women who are pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT03593005', 'briefTitle': 'Acute Exposure to High Altitude on Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise', 'orgStudyIdInfo': {'id': '2018-00455_B2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Order A', 'description': 'The participants will be tested in the following order: Zurich (Low altitude: 470m above sea level) and consecutively High Altitude (Säntis; 2500m above sea Level)', 'interventionNames': ['Other: Assessment at Low Altitude (470m above sea level)', 'Other: Exposure to High Altitude (2500m above sea level)']}, {'type': 'EXPERIMENTAL', 'label': 'Order B', 'description': 'The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level).', 'interventionNames': ['Other: Assessment at Low Altitude (470m above sea level)', 'Other: Exposure to High Altitude (2500m above sea level)']}], 'interventions': [{'name': 'Assessment at Low Altitude (470m above sea level)', 'type': 'OTHER', 'description': 'Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure', 'armGroupLabels': ['Order A', 'Order B']}, {'name': 'Exposure to High Altitude (2500m above sea level)', 'type': 'OTHER', 'description': 'Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours', 'armGroupLabels': ['Order A', 'Order B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Respiratory Clinic, University Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Silvia Ulrich, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}