Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-02-26 @ 3:23 AM
Study NCT ID:
NCT06384534
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2024-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each participant is its own control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air', 'timeFrame': 'after 6 minutes', 'description': 'Change in 6MWD in meter between SOT via nasal cannula vs. ambient air'}], 'secondaryOutcomes': [{'measure': 'SpO2 at rest and peak 6MWD with SOT vs. ambient air', 'timeFrame': 'after 6 minutes', 'description': 'Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with SOT approximately 3l /min vs. ambient air'}, {'measure': 'Heart rate at rest and peak 6MWD with SOT vs. ambient air', 'timeFrame': 'after 6 minutes', 'description': 'Change of heart rate (bpm) at rest and at peak 6MWD with SOT vs. ambient air'}, {'measure': 'Borg dyspnea atrest and peak 6MWD with SOT vs. ambient air', 'timeFrame': '6 minutes', 'description': 'Change of Borg dyspnea scale (CR10, 0-10 where 10 is the worst dyspnea) at rest and at peak 6MWD with SOT vs. ambient air'}, {'measure': 'Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air', 'timeFrame': '6 minutes', 'description': 'Change of Borg leg fatigue scale (CR10, 0-10 where 10 is the strongest led fatugue) at rest and at peak 6MWD with SOT vs. ambient air'}, {'measure': 'Blood pressure at rest and peak 6MWD with SOT vs. ambient air', 'timeFrame': 'after 6 minutes', 'description': 'Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT vs. ambient air'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Supplemental Oxygen Therapy', 'Pulmonary Arterial Hypertension', 'Chronic Thromboembolic Pulmonary Hypertension', 'Pulmonary Vascular Disease', '6 Minute Walking Distance'], 'conditions': ['Pulmonary Vascular Disorder', 'Chronic Thromboembolic Pulmonary Hypertension', 'Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).', 'detailedDescription': 'Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT approximately 3l/min via nasal cannula according to a randomized cross-over design.\n\nThe trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.\n\nThe effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum 18 years of age\n* Written informed consent\n* Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH)\n* Former desaturation under exercise defined as Spo2-decrease \\>3%\n* Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)\n\nExclusion Criteria:\n\n* Severe hypoxemia needing supplemental oxygen therapy defined as partial pressure of O2 (PaO2) \\< 6.9 Kilopascal (kPa)\n* Pregnancy\n* Unability or contraindications to undergo the investigated intervention\n* Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc'}, 'identificationModule': {'nctId': 'NCT06384534', 'briefTitle': 'Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Oxygen Therapy - a Non-inferiority Trial in Patients With Exercise Induced Desaturation Due to Pulmonary Vascular Disease (PVD)', 'orgStudyIdInfo': {'id': 'PVD_6MWD_SOT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ambient air', 'description': 'Patient will perform tests at University Hospital Zurich', 'interventionNames': ['Other: 6-minute walk distance (6MWD) test on ambient air']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOT via basal canula', 'description': 'Supplemental Oxygen Therapy (SOT) at approximately 3l/min will be provided via nasal canula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich.', 'interventionNames': ['Other: 6-minute walk distance test with supplemental oxygen']}], 'interventions': [{'name': '6-minute walk distance (6MWD) test on ambient air', 'type': 'OTHER', 'description': '6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards', 'armGroupLabels': ['Ambient air']}, {'name': '6-minute walk distance test with supplemental oxygen', 'type': 'OTHER', 'description': '6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (approximately 3l/min, nasal)', 'armGroupLabels': ['SOT via basal canula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Silvia Ulrich, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Department of Pulmonology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be provided upon request and based on a clear intention reviewed by an ethical review board'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}