Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT02777957
Status:
UNKNOWN
Last Update Posted:
2020-05-27
First Post:
2016-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Pulmonary Hypertension in Patients With Advanced Lung Diseases
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-25', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-05-18', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival after the initial right heart catheterization (RHC) measurements', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Survival to lung transplantation or the end of the observation period after the initial right heart catheterization (RHC) measurement', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Echocardiography', 'Lung Transplantation'], 'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '28052583', 'type': 'BACKGROUND', 'citation': 'Nowak J, Hudzik B, Jastrzebski D, Niedziela JT, Rozentryt P, Wojarski J, Ochman M, Karolak W, Zeglen S, Gierlotka M, Gasior M. Pulmonary hypertension in advanced lung diseases: Echocardiography as an important part of patient evaluation for lung transplantation. Clin Respir J. 2018 Mar;12(3):930-938. doi: 10.1111/crj.12608. Epub 2017 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'First, the aim of the study was to evaluate the usefulness of echocardiographic parameters for detecting pulmonary hypertension (PH) in patients with advanced lung disease referred for lung transplantation. Second, to assess the prevalence of PH and to identify which hemodynamic, echocardiographic, pulmonary functional test, exercise capacity and biochemical parameters (especially NT-proBNP) have an impact on survival in a cohort of patients with severe lung diseases referred for lung transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with advanced lung diseases referred for lung transplantation. All patients underwent examinations as potential candidates for lung transplantation, including laboratory testing, pulmonary function tests, exercise capacity, echocardiography examination, and right heart catheterization. Evaluation for lung transplantation was performed during clinically stable periods in all patients on optimal medical and oxygen therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* advanced lung disease\n* qualification for lung transplantation\n* written informed consent\n* pulmonary capillary wedge pressure \\< 15 mmHg\n\nExclusion Criteria:\n\n* cancer,\n* history of idiopathic pulmonary hypertension,\n* primary valvular heart diseases,\n* coronary artery disease,\n* collagen vascular disease,\n* history or evidence of left ventricular dysfunction,\n* atrial fibrillation,\n* increased liver enzyme levels ( 3 times the upper laboratory limit),\n* renal dysfunction (estimated glomerular filtration rate \\< 60 ml/min/1.73m2)\n* patients who didn't write the personal informed consent\n* any specific therapy for PH."}, 'identificationModule': {'nctId': 'NCT02777957', 'briefTitle': 'Predictors of Pulmonary Hypertension in Patients With Advanced Lung Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Silesian Centre for Heart Diseases'}, 'officialTitle': 'Predictors and Survival in Pulmonary Hypertension Associated With Severe Lung Disease', 'orgStudyIdInfo': {'id': 'SilesianCHD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mPAP ≥ 25 mmHg', 'description': 'mean pulmonary artery pressure (mPAP) ≥ 25 mmHg (37 patients)'}, {'label': 'mPAP < 25 mmHg', 'description': 'mean pulmonary artery pressure (mPAP) \\< 25 mmHg (28 patients).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41-800', 'city': 'Zabrze', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Silesian Centre for Heart Diseases', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}], 'overallOfficials': [{'name': 'Jolanta Nowak, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '3rd Department of Cardiology, Silesian Centre for Heart Diseases'}, {'name': 'Mariusz Gasior, Prof., PhD', 'role': 'STUDY_CHAIR', 'affiliation': '3rd Department of Cardiology, Silesian Centre for Heart Diseases'}, {'name': 'Slawomir Zeglen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Departament of Cardiac Surgery and Transplantology, Silesian Centre for Heart Diseases'}, {'name': 'Jacek Wojarski, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Departament of Cardiac Surgery and Transplantology, Silesian Centre for Heart Diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silesian Centre for Heart Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jolanta Nowak', 'investigatorAffiliation': 'Silesian Centre for Heart Diseases'}}}}