Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
Study NCT ID:
NCT02580903
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2015-01-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulmonary Hypertension in Patients With Myeloproliferative Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'All patients will submit a blood sample for later analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2015-01-31', 'studyFirstSubmitQcDate': '2015-10-19', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of pulmonary hypertension at initial presentation and first echo', 'timeFrame': 'Initial recruitment'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '1 and 5 years'}, {'measure': 'Incidence of pulmonary hypertension while under follow-up', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myeloproliferative Disorders', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'This is an observational prospective study aiming to clarify the prevalence of pulmonary hypertension in patients with Myeloproliferative Neoplasms and their prognosis.\n\nAll patients attending our department with the above mentioned neoplasms will be offered inclusion in this study. All will have an echo performed and patients identified as being at risk of pulmonary hypertension will be offered complete investigation as specified by the European Cardiology Association.\n\nAll patients will be followed up for a total of five years to identify prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending our outpatient clinic with Myeloproliferative Neoplasms', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myeloproliferative Neoplasms (PV, ET, PMF according to WHO classification)\n\nExclusion Criteria:\n\n* Pregnancy\n* Lack of informed consent\n* Age \\< 18 years\n* Cognitive dysfunctions'}, 'identificationModule': {'nctId': 'NCT02580903', 'acronym': 'MPNPH', 'briefTitle': 'Pulmonary Hypertension in Patients With Myeloproliferative Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Pulmonary Hypertension in Patients With Philadelphia Chromosome Negative Myeloproliferative Neoplasms; an Observational Prospective Study', 'orgStudyIdInfo': {'id': 'MPNPH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Radiology', 'type': 'RADIATION', 'description': 'Only a small subsample will require CT and right heart catherisation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Mette Brabrand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Specialist', 'investigatorFullName': 'Mette Brabrand', 'investigatorAffiliation': 'Odense University Hospital'}}}}