Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-27 @ 9:55 PM
Study NCT ID:
NCT06489756
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2024-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Highlanders With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Arterial Pressure (PAP) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535833', 'term': 'Pulmonary edema of mountaineers'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'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': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each highlander with HAPH will perform a echocardiography with and without SOT according to a cross-over design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2024-06-28', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pulmonary Artery Pressure with SOT vs.ambient air at 3200m', 'timeFrame': 'at 15 min of breathing ambient air or supplemental oxygen', 'description': 'Change in RV/RA in mmHg assessed by echocardiography with SOT compared to ambient air at 3200m'}], 'secondaryOutcomes': [{'measure': 'Change in Cardiac Output with SOT vs. ambient air at 3200m', 'timeFrame': 'at 15 min of breathing ambient air or supplemental oxygen', 'description': 'Change in cardiac output (l/min) assessed by echocardiography with SOT compared to ambient air at 3200m'}, {'measure': 'Change in right to left heart diameter ratio with SOT vs.ambient air at 3200m', 'timeFrame': 'at 15 min of breathing ambient air or supplemental oxygen', 'description': 'Change in right to left heart diameter ratio assessed by echocardiography with SOT compared to ambient air at 3200m'}, {'measure': 'Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs.ambient air at 3200m', 'timeFrame': 'at 15 min of breathing ambient air or supplemental oxygen', 'description': 'Change in tricuspid annular plane systolic excursion (TAPSE) with SOT compared to ambient air at 3200m'}, {'measure': 'Change in right atrial area with SOT vs. ambient air at 3200m', 'timeFrame': 'at 15 min of breathing ambient air or supplemental oxygen', 'description': 'Change in right atrial area by echocardiography with SOT compared to ambient air at 3200m'}, {'measure': 'Change in right heart strain with SOT vs. ambient air at 3200m', 'timeFrame': 'at 15 min of breathing ambient air or supplemental oxygen', 'description': 'Change in right heart strain by echocardiography with SOT compared to ambient air at 3200m'}, {'measure': 'Change in pH by arterial blood gases with SOT vs. ambient air at 3200m', 'timeFrame': 'at 15 min of breathing ambient air or supplemental oxygen', 'description': 'Changes in pH by arterial blood gases with SOT compared to ambient air at 3200m'}, {'measure': 'Change in PaO2 by arterial blood gases with SOT vs. ambient air at 3200m', 'timeFrame': 'at 15 min of breathing ambient air or supplemental oxygen', 'description': 'Changes in PaO2 by arterial blood gases with SOT compared to ambient air at 3200m'}, {'measure': 'Change in PaCO2 by arterial blood gases with SOT vs. ambient air at 3200m', 'timeFrame': 'at 15 min of breathing ambient air or supplemental oxygen', 'description': 'Changes in PaCO2 by arterial blood gases with SOT compared to ambient air at 3200m'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Hypoxia', 'High Altitude', 'Supplemental Oxygen Therapy', 'Pulmonal Arterial Pressure'], 'conditions': ['High Altitude Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The investigators aim to study the effect of SOT in highlanders with high altitude pulmonary hypertension (HAPH) who permanently live \\>2500m on pulmonary arterial pressure (PAP) assessed at 3200 m.', 'detailedDescription': 'Highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA (Tricuspid Regurgitation Pressure Gradient) \\>30 mmHg will be recruited for this project. Highlanders permanently living at HA \\>2500 m will have echocardiografy to assess PAP near their living altitude in Aksay at 3200 m with and without 10L/min supplemental oxygen therapy (SOT) via face mask.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Permanently living \\>2500 m\n* HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m\n* Written informed consent\n\nExclusion Criteria:\n\n* Highlanders who cannot follow the study investigations,\n* Patients with moderate to severe concomitant lung disease (FEV1\\<70% or forced vital capacity \\<70%), severe parenchymal lung disease, heavy smoking \\>20 cigarettes/day or \\>20 pack-years.\n* Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months\n* Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)'}, 'identificationModule': {'nctId': 'NCT06489756', 'briefTitle': 'Highlanders With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Arterial Pressure (PAP) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effect of Supplemental Oxygen Therapy (SOT) on Pulmonary Arterial Pressure in Highlanders With High Altitude Pulmonary Hypertension Permanently Living at >2500m', 'orgStudyIdInfo': {'id': 'HAPH_SOT_PAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ambient air', 'description': 'Highlanders with HAPH will perform the echocardiography on ambient air at 3200m', 'interventionNames': ['Other: Echocardiography']}, {'type': 'EXPERIMENTAL', 'label': '10 L/min SOT through face mask', 'description': 'Supplemental oxygen therapy (SOT) at 10 L/min will be provided via face mask from oxygen concentrators', 'interventionNames': ['Other: Echocardiography']}], 'interventions': [{'name': 'Echocardiography', 'type': 'OTHER', 'description': 'Echocardiography will be performed according to clinical standards', 'armGroupLabels': ['10 L/min SOT through face mask', 'Ambient air']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aksay Plateau, Naryn, Kyrgyzstan', 'country': 'Kyrgyzstan', 'facility': 'Aksay Medical Center'}], 'overallOfficials': [{'name': 'Talant MA Sooronbaev, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov'}, {'name': 'Silvia Ulrich, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Department of Pulmonology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}