Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-29 @ 6:41 AM
Study NCT ID:
NCT04654650
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2020-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients with Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2041-01-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2020-11-29', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2041-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transplant-free survival', 'timeFrame': 'Up to 20 years of follow-up after enrollment'}], 'secondaryOutcomes': [{'measure': 'Risk score (averaging low, intermediate and high risk categories) as proposed by the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for pulmonary hypertension', 'timeFrame': 'Up to 20 years of follow-up after enrollment'}, {'measure': 'Registry to Evaluate Early And Long-term PAH Disease Management (REVEAL) 2.0 risk score', 'timeFrame': 'Up to 20 years of follow-up after enrollment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Prospective registry and biobank for long-term observational studies in adult patients with pulmonary hypertension', 'detailedDescription': 'In a prospective registry prevalent and incident patients diagnosed with group 1 to 5 pulmonary hypertension will be enrolled. In an integrated biobank body fluid samples will be collected at enrollment and sequentially during treatment with targeted drugs for pulmonary hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with pulmonary hypertension and patients referred to a pulmonary hypertension center for suspected pulmonary hypertension.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of pulmonary hypertension group 1 to 5\n* Ability to give informed consent\n\nExclusion Criteria:\n\n\\- Withdrawal of informed consent'}, 'identificationModule': {'nctId': 'NCT04654650', 'briefTitle': 'Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients with Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients with Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'HHPHBiobank'}}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Lars Harbaum', 'role': 'CONTACT', 'email': 'l.harbaum@uke.de'}], 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Lars Harbaum, MD', 'role': 'CONTACT', 'email': 'l.harbaum@uke.de', 'phone': '+4940741018337'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}