Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-01 @ 2:53 PM
Study NCT ID:
NCT00949195
Status:
UNKNOWN
Last Update Posted:
2011-07-21
First Post:
2009-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Arterial Pressure Response During Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014691', 'term': 'Ventilation'}, {'id': 'D002097', 'term': 'C-Reactive Protein'}], 'ancestors': [{'id': 'D004780', 'term': 'Environment, Controlled'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000209', 'term': 'Acute-Phase Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D007162', 'term': 'Immunoproteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': "Blood sample is taken to analyse the systemic inflammatory marker (hsCRP) level from serum. We measure the samples and than we don't store it."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-20', 'studyFirstSubmitDate': '2009-07-29', 'studyFirstSubmitQcDate': '2009-07-29', 'lastUpdatePostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The degree of pulmonary artery pressure change during exercise?', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Right ventricular function change? Correlation between systemic inflammation (hsCRP) and pulmonary artery pressure change? Endothelial dysfunction?', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'healthy patients', 'PAP', 'CPX', 'SSE', 'hsCRP', 'FMD'], 'conditions': ['COPD Patients', 'Healthy Subjects', 'Semi-supine Echo (SSE)', 'Flow-mediated Vasodilatation (FMD)', 'High Sensitive C-reactive Protein (hsCRP)']}, 'referencesModule': {'references': [{'pmid': '27019674', 'type': 'DERIVED', 'citation': 'Varga J, Palinkas A, Lajko I, Horvath I, Boda K, Somfay A. Pulmonary Arterial Pressure Response During Exercise in COPD: A Correlation with C-Reactive Protein (hsCRP). Open Respir Med J. 2016 Jan 29;10:1-11. doi: 10.2174/1874306401610010001. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nThe extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in patients with COPD is unpredictable from lung function data. The non-invasive assessment of pulmonary hemodynamics during exercise and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of COPD patients.\n\nMethods:\n\nPatients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange detection. Serum hsCRP level is also determined in COPD patients. Endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with Doppler ultrasonography.\n\nPrimary endpoint:\n\nThe degree of pulmonary artery systolic pressure change during exercise?\n\nSecondary endpoint:\n\n1. The degree of right ventricular function change during exercise?\n2. Is endothel dysfunction manifested with pulmonary artery pressure rise?\n3. What is the correlation between the systemic inflammatory marker hsCRP and the degree of pulmonary artery pressure rise?', 'detailedDescription': 'Background: The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in patients with COPD is unpredictable from lung function data. The non-invasive assessment of pulmonary hemodynamics during exercise by semi-supine echocardiography and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of COPD patients.\n\nMethods: Patients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange detection. Serum hsCRP level is also determined in COPD patients. All of the subjects perform complete lung function with body pletysmography and diffusion capacity measurement. Endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with Doppler ultrasonography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients (age between 45 and 70) with moderate to severe obstruction (FEV1\\<60%) and healthy subjects (age between 45 and 70)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients (age between 45 and 70)\n* with moderate to severe obstruction (FEV1\\<60%pred) and\n* healthy subjects (age between 45 and 70, (FEV1\\>80%pred, FEV1/FVC\\>70%\n\nExclusion Criteria:\n\n* Not in the age range\n* Different FEV1 value\n* Severe comorbidities'}, 'identificationModule': {'nctId': 'NCT00949195', 'acronym': 'PAPCOPDHS', 'briefTitle': 'Pulmonary Arterial Pressure Response During Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Szeged University'}, 'officialTitle': 'Pulmonary Arterial Pressure Response During Exercise in COPD and Healthy Subjects', 'orgStudyIdInfo': {'id': 'SZTE PULM-PAHP'}, 'secondaryIdInfos': [{'id': 'ISRCTN11034505'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD patients', 'description': 'COPD patients with severe obstruction performed the tests.', 'interventionNames': ['Other: Measure pulmonary artery pressure change during exercise', 'Other: Pulmonary pressure response during exercise']}, {'label': 'Healthy subjects', 'description': 'Age-matched healthy subjects performed the same test also.', 'interventionNames': ['Other: Measure pulmonary artery pressure change during exercise', 'Other: Pulmonary pressure response during exercise']}], 'interventions': [{'name': 'Measure pulmonary artery pressure change during exercise', 'type': 'OTHER', 'otherNames': ['lung function, CPX, HsCRP'], 'description': 'Semi-supine echocardiography test', 'armGroupLabels': ['COPD patients', 'Healthy subjects']}, {'name': 'Pulmonary pressure response during exercise', 'type': 'OTHER', 'otherNames': ['Complete lung function, CPX, HsCRP'], 'description': 'Semi-supine echocardiography test', 'armGroupLabels': ['COPD patients', 'Healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6772', 'city': 'Deszk', 'state': 'Csongrád megye', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Attila Somfay, MD, PhD', 'role': 'CONTACT', 'email': 'somfay@deszk.szote.u-szeged.hu', 'phone': '+36-62-571-552'}, {'name': 'Janos Varga, MD', 'role': 'CONTACT', 'email': 'janosvargaster@gmail.com', 'phone': '+36-62-571-527, +36209204235'}, {'name': 'Attila Somfay, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Janos Varga, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Imre Lajko, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Pulmonology, Szeged University', 'geoPoint': {'lat': 46.21802, 'lon': 20.24322}}], 'centralContacts': [{'name': 'Attila Somfay, MD, PhD', 'role': 'CONTACT', 'email': 'somfay@deszk.szote.u-szeged.hu', 'phone': '+36-62-571-551'}, {'name': 'Janos Varga, MD', 'role': 'CONTACT', 'email': 'janosvargaster@gmail.com', 'phone': '+36-62-571-527, +36209204235'}], 'overallOfficials': [{'name': 'Attila Somfay, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pulmonology, Szeged University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Szeged University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Attila Somfay, MD, PhD; Department Leader', 'oldOrganization': 'Department of Pulmonology, Szeged University'}}}}