Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-03-03 @ 3:04 PM
Study NCT ID:
NCT03637218
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2018-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Exposure of High Altitude on Cardiac Output
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': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Output measured non-invasively', 'timeFrame': 'Averaged over two minutes rest and 30 seconds end of exercise (exhaustion)', 'description': 'Change in non-invasive assessed cardiac output measured with a finger cuff (Finapres) during the exposure to High Altitude (2500m) compared to Low Altitude (Zurich; 470m)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Altitude', 'non-invasive cardiac output', 'Finapres'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response High Altitude (Säntis; 2500m above sea level) on non-invasive cardiac output assessments by Finapres® NOVA Technology at rest and under exercise', '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 in Low Altitude (Zurich, 470m) and at High Altitude (2500m).\n\nDuring the exposure High Altitude (2500m) and Low Altitude (Zurich; 470m) up to 5 hours, the participants cardiac output non-invasively assessed will be measured repetitive during the whole intervention.'}, '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': 'NCT03637218', 'briefTitle': 'Acute Exposure of High Altitude on Cardiac Output', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Acute Exposure of Simulated Hypoxia on Non-invasive Cardiac Output Assessments at Rest and During Exercise', 'orgStudyIdInfo': {'id': '2018-00455_B8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Order A', 'description': 'The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at 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'}}}}