Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-02 @ 5:14 AM
Study NCT ID:
NCT06489704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Altitude (HA) Residents With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Artery Pressure (PAP) Assessed at HA (3200 m) vs LA (760 m)
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each highlander with HAPH will perform a echocardiography at high altitude (HA, 3200 m) and day 2 and day 7 at low altitude (LA, 760 m) according to a prospective study design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2024-06-28', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pulmonary artery Pressure (PAP) after the first night at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'day 2 at 760 m vs. 3200 m', 'description': 'Change in RV/RA in mmHg assessed by echocardiography between LA (760 m) vs High altitude (3200 m)'}], 'secondaryOutcomes': [{'measure': 'Change in Pulmonary artery Pressure (PAP) after seven nights at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'day 7 at 760 m vs. 3200 m', 'description': 'Change in RV/RA in mmHg assessed by echocardiography between LA (760 m) vs High altitude (3200 m)'}, {'measure': 'Cardiac output at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'day 2 and 7 at 760 m vs. 3200 m', 'description': 'Change in cardiac output in l/min assessed by echocardiography between LA (760 m) vs HA (3200 m)'}, {'measure': 'Tricuspid pressure gradient by echocardiography at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'day 2 and 7 at 760 m vs. 3200 m', 'description': 'Tricuspid pressure gradient assessed by echocardiography between LA (760 m) vs HA (3200 m)'}, {'measure': 'Tricupsid annular plane systolic excursion by echocardiography at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'day 2 and 7 at 760 m vs. 3200 m', 'description': 'Tricupsid annular plane systolic excursion assessed by echocardiography between LA (760 m) vs HA (3200 m)'}, {'measure': 'pH by arterial blood gases at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'day 2 and 7 at 760 m vs. 3200 m', 'description': 'Change in pH by arterial blood gases assessed between LA (760 m) vs HA (3200 m)'}, {'measure': 'partial pressure of oxygen (PaO2) by arterial blood gases at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'day 2 and 7 at 760 m vs. 3200 m', 'description': 'Change in partial pressure of oxygen (PaO2) assessed by arterial blood gases between LA (760 m) vs HA (3200 m)'}, {'measure': 'partial pressure of carbon dioxide (PaCO2) by arterial blood gases at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'after the first and seventh night at LA', 'description': 'Change in partial pressure of carbon dioxide (PaCO2) assessed by arterial blood gases partial pressure of carbon dioxide (PaCO2) between LA (760 m) vs HA (3200 m)'}, {'measure': 'Change in right to left heart diameter ratio at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'day 2 and 7 at 760 m vs. 3200 m', 'description': 'Change in right to left heart diameter ratio assessed by echocardiography between LA (760 m) vs HA (3200 m)'}, {'measure': 'Change in right atrial area at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'day 2 and 7 at 760 m vs. 3200 m', 'description': 'Change in right atrial area by echocardiography between LA (760 m) vs HA (3200 m)'}, {'measure': 'Change in right heart strain at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'day 2 and 7 at 760 m vs. 3200 m', 'description': 'Change in right heart strain by echocardiography between LA (760 m) vs HA (3200 m)'}, {'measure': 'Change in ECG morphology at 760 m (LA) vs at 3200 m (HA)', 'timeFrame': 'day 2 and 7 at 760 m vs. 3200 m', 'description': 'Change in ECG morphology and QT-interval by 12-lead ECG between LA (760 m) vs HA (3200 m)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Hypoxia', 'High Altitude', 'Pulmonal Arterial Pressure'], 'conditions': ['High Altitude Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'To study the effect of relocation from 3200 m (Aksay) to 760 m (Bishkek) in patients with high altitude pulmonary hypertension (HAPH) who permanently live \\>2500 m on pulmonary artery pressure (PAP)', 'detailedDescription': 'This research in highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA \\>30 mmHg who permanently live at HA \\>2500 m will have pulmonary arterial pressure (PAP) assessed by echocardiography near their living altitude in Aksay at 3200 m and at 760 m in Bishkek the day after the first and the seventh night after relocation.'}, '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': 'NCT06489704', 'briefTitle': 'High Altitude (HA) Residents With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Artery Pressure (PAP) Assessed at HA (3200 m) vs LA (760 m)', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Comparative Study of Pulmonary Artery Pressure (PAP) Assessed by Echocardiography in Patients With High Altitude Pulmonary Hypertension (HAPH) Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200 m vs. at Low Altitude (LA) at 760 m', 'orgStudyIdInfo': {'id': 'HAPH_HAvsLA_PAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Assessments at 3200 m and 760 m, respectively', 'description': 'Participants will have a echocardiography near their resident altitude at 3200 m and after relocation to 760 m after 1 and 7 days', 'interventionNames': ['Other: Echocardiography']}], 'interventions': [{'name': 'Echocardiography', 'type': 'OTHER', 'description': 'Echocardiography will be performed according to clinical standards', 'armGroupLabels': ['Assessments at 3200 m and 760 m, respectively']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan', 'country': 'Kyrgyzstan', 'contacts': [{'name': 'Talant M Sooronbaev, Prof. Dr.', 'role': 'CONTACT', 'phone': '+996772574567'}], 'facility': 'Aksay Medical Center'}], 'centralContacts': [{'name': 'Silvia Ulrich, Prof. Dr.', 'role': 'CONTACT', 'email': 'silvia.ulrich@usz.ch', 'phone': '+41442552220'}, {'name': 'Michael Furian, Prof. Dr.', 'role': 'CONTACT', 'email': 'michael.furian@usz.ch', 'phone': '+41442552220'}], 'overallOfficials': [{'name': 'Talant M 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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}