Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-01 @ 7:36 PM
Study NCT ID:
NCT00909467
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2009-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples with DNA will be retained for later examinations at the Department for Genetics, if the patient agrees with it (specific question at the patient information).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-08', 'studyFirstSubmitDate': '2009-05-27', 'studyFirstSubmitQcDate': '2009-05-27', 'lastUpdatePostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean pulmonary arterial pressure at rest and during exercise', 'timeFrame': 'at baseline and after 1 year'}], 'secondaryOutcomes': [{'measure': 'exercise capacity', 'timeFrame': 'at baseline and after 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myeloproliferative Disorder', 'Myelodysplastic Syndromes', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Myelodysplastic and myeloproliferative Disease represent conditions with increased risk for pulmonary hypertension. However, the exact prevalence of pulmonary hypertension in these conditions is not known. The effects of pulmonary hypertension on the clinical picture and the symptoms of patients in these conditions needs also further exploration. This exploratory study is designed to describe the prevalence of pulmonary hypertension in the population with such hematologic diseases, and the stages of pulmonary hypertension as well its effect on exercise capacity at time of diagnosis.', 'detailedDescription': 'For early recognition of pulmonary hypertension exercise doppler echocardiography will be used in all patients. Patients with elevated pulmonary arterial pressure at rest or during exercise (estimated by echocardiography), or with decreased exercise capacity (as a potential sign of pulmonary hypertension) are advised to undergo right heart catheterisation. Cardiopulmonary exercise testing and six-minute walk distance measurement are performed to measure exercise capacity. The described work-up of patients allows precise and objective hemodynamic and clinical evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with known myeloproliferative or myelodysplastic disease as a risk factor for pulmonary hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* myelodysplastic disease or myeloproliferative diseases\n\nExclusion Criteria:\n\n* known pulmonary hypertension\n* relevant pulmonary disease\n* relevant left cardiac or valvular disease\n* recent major operations\n* recent changes in medications\n* relevant anaemia\n* inability to exercise'}, 'identificationModule': {'nctId': 'NCT00909467', 'briefTitle': 'Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases', 'orgStudyIdInfo': {'id': '20-097 ex 08/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'myeloproliferative, -dysplastic disease', 'interventionNames': ['Other: echocardiography, right heart catheterisation']}], 'interventions': [{'name': 'echocardiography, right heart catheterisation', 'type': 'OTHER', 'otherNames': ['EDE, RHC'], 'description': 'at each patient an echocardiography will be performed at rest and during exercise. For the evaluation of exercise capacity, cardiopulmonary exercise testing and six-minute walk is performed. Right heart catheterisation is recommended to those with suspected pulmonary hypertension.', 'armGroupLabels': ['myeloproliferative, -dysplastic disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz, Pulmonology', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Horst Olschewski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz, Pulmonology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}