Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-02 @ 12:22 AM
Study NCT ID:
NCT03581851
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2018-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Exposure of Simulated Hypoxia on ECG and Non-invasive Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The allocated gas mixture will not be disclosed to the patient since he will breath trough a facemask during both interventions.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Including a baseline assessment and assessments under simulated altitude and normoxia'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2018-06-20', 'studyFirstSubmitQcDate': '2018-07-09', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-invasive blood pressure (Finapres)', 'timeFrame': '1 hour', 'description': 'Change in non-invasive bloodpressure (systolic and diastolic) assessed with a finger cuff (Finapres) during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia'}], 'secondaryOutcomes': [{'measure': 'Electrocardiography', 'timeFrame': '1 hour', 'description': 'Change in cardiac repolarization during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['simulated altitude', 'exercise', 'electrocardiography', 'non- invasive blood pressure'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FIO2: 15.1% = equivalent to 2500m above sea level) on ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology.', 'detailedDescription': 'Low altitude baseline measurements will be performed in Zurich (469m asl) including Echocardiography, right heart catheterization, six Minute Walking test (6MWT), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise. Randomly assigned to the order of testing, the participants will e tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device. During the exposure to simulated altitude (FiO2: 15.1%) and shamed altitude of 1 hour each, the participants\' ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected.'}, '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: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (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 partial O2 pressure (PaO2) ≤7.3 kiloPascal (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, High Altitude Pulmonary Edema (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': 'NCT03581851', 'briefTitle': 'Acute Exposure of Simulated Hypoxia on ECG and Non-invasive Blood Pressure', '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_A5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Order Sham/Hypoxia', 'description': 'The participants will be consecutively exposed to shamed hypoxia (FiO2: 20.9%) equivalent to sea level and to simulated altitude (FiO2: 15.1%) equivalent to 2500m above sea level administered by an altitude simulator ("Altitrainer", SMTEC) with a facemask.', 'interventionNames': ['Device: Simulated Altitude: (FiO2: 15.1)', 'Device: Shamed Hypoxia (FiO2: 20.9)']}, {'type': 'EXPERIMENTAL', 'label': 'Order Hypoxia/Sham', 'description': 'The participants will be consecutively exposed to hypoxia (FiO2: 15,1%) equivalent to 2500m above sea level and to shamed hypoxia (FiO2: 20.9%) equivalent to sea level administered by an altitude simulated ("Altitrainer", SMTEC) with a facemask.', 'interventionNames': ['Device: Simulated Altitude: (FiO2: 15.1)', 'Device: Shamed Hypoxia (FiO2: 20.9)']}], 'interventions': [{'name': 'Simulated Altitude: (FiO2: 15.1)', 'type': 'DEVICE', 'description': 'Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.', 'armGroupLabels': ['Order Hypoxia/Sham', 'Order Sham/Hypoxia']}, {'name': 'Shamed Hypoxia (FiO2: 20.9)', 'type': 'DEVICE', 'description': 'Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.', 'armGroupLabels': ['Order Hypoxia/Sham', 'Order Sham/Hypoxia']}]}, '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, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}