Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT05996302
Status:
UNKNOWN
Last Update Posted:
2023-10-03
First Post:
2023-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065627', 'term': 'Familial Primary Pulmonary Hypertension'}, {'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': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients living permanently \\>2500m around Quito (Equador) will be assessed at 2850m and after relocation to sea level'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2023-08-09', 'studyFirstSubmitQcDate': '2023-08-09', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-minute walk distance (6MWD) after the first night at LA', 'timeFrame': 'after the first night at LA (sea level)', 'description': 'Change in 6MWD in meter between LA (sea level) vs HA (2840 m)'}], 'secondaryOutcomes': [{'measure': '6-minute walk distance (6MWD) after the second night at LA', 'timeFrame': 'after the second night at LA (sea level)', 'description': 'Change in 6MWD in meter between LA (sea level) vs HA (2840 m)'}, {'measure': 'Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA', 'timeFrame': 'after the first night at LA (sea level)', 'description': 'Change in SpO2 in % between LA (sea level) vs HA (2840 m)'}, {'measure': 'Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA', 'timeFrame': 'after the second night at LA (sea level)', 'description': 'Change in SpO2 in % between LA (sea level) vs HA (2840 m)'}, {'measure': 'Heart rate at rest and at peak 6MWD after the first night at LA', 'timeFrame': 'after the first night at LA (sea level)', 'description': 'Change in heart rate in bpm between LA (sea level) vs HA (2840 m)'}, {'measure': 'Heart rate at rest and at peak 6MWD after the second night at LA', 'timeFrame': 'after the second night at LA (sea level)', 'description': 'Change in heart rate in bpm between LA (sea level) vs HA (2840 m)'}, {'measure': 'Blood pressure at rest and at peak 6MWD after the first night at LA', 'timeFrame': 'after the first night at LA (sea level)', 'description': 'Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)'}, {'measure': 'Blood pressure at rest and at peak 6MWD after the second night at LA', 'timeFrame': 'after the second night at LA (sea level)', 'description': 'Change in blood pressure in mmHg between LA (sea level) vs HA (2840 m)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Hypoxia', '6-minute walk test', 'High altitude', 'Pulmonary Artery Hypertension', 'Chronic Thromboembolic Pulmonary Hypertension'], 'conditions': ['Pulmonary Vascular Disease', 'Pulmonary Artery Hypertension', 'Chronic Thromboembolic Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live \\>2500m on 6-minute walk distance (6MWD)', 'detailedDescription': 'This research in patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA \\>2500 (PVDHA) will have 6-minute walk distance near their living altitude in Quito at 2840m and at sea level in Pedernales the day after the first and the second night after relocation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients 18-80 years old of both genders,\n* Residence \\> 2500m of altitude\n* diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) \\>20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines\n* Patients stable on therapy\n* NYHA (new york heart association) functional class I-III\n* Provided written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Age \\<18 years or \\>80 years\n* unstable condition\n* Patients who cannot follow the study investigations, patient permanently living \\< 2500m.\n* Patients with moderate to severe concomitant lung disease (FEV1\\<70% or forced vital capacity \\<70%), severe parenchymal lung disease, severe smokers (\\>20 igarettes/day)\n* Severely hypoxemic patients at Quito permanently have persistent SpO2 (oxygen saturation by pulseoximetry) \\<80% on ambient air.\n* Patients with chronic mountain sickness (Hemoglobin \\> 19 g/dl in women, \\>21 g/dl in men)\n* Patient with a non-corrected ventricular septum defect\n* Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\\<11 g/dl)'}, 'identificationModule': {'nctId': 'NCT05996302', 'briefTitle': 'HA Residents With PVD, 6MWD Assessed at HA (2840m) vs LA (Sea Level)', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Comparative Study of 6-minute Walk Distance (6MWD) in Patients With Pulmonary Vascular Diseases Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 2840m vs. at Low Altitude (LA) Sea Level.', 'orgStudyIdInfo': {'id': 'PVD_HAvsLA_6MWD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '6-minute walk distance at 2840m', 'description': 'Participants will have 6-minute walk distance (6MWD) assessment near their resident altitude at 2840m', 'interventionNames': ['Behavioral: Relocation to sea level']}, {'type': 'EXPERIMENTAL', 'label': '6-minute walk distance at sea level', 'description': 'Participants will have 6-minute walk distance (6MWD) assessment at sea level (0-30m)', 'interventionNames': ['Behavioral: Relocation to sea level']}], 'interventions': [{'name': 'Relocation to sea level', 'type': 'BEHAVIORAL', 'description': 'Relocation to sea level by bus and stay for 2 days', 'armGroupLabels': ['6-minute walk distance at 2840m', '6-minute walk distance at sea level']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Silvia Ulrich, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Departement of Pulmonology'}, {'name': 'Rodrigo Hoyos, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carlos Adrade Marin Hospital of Quito, Equador'}]}, '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'}}}}