Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-28 @ 2:12 AM
Study NCT ID:
NCT01270750
Status:
UNKNOWN
Last Update Posted:
2011-01-28
First Post:
2011-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bosentan for Severe Mitral Valve Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008946', 'term': 'Mitral Valve Stenosis'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077300', 'term': 'Bosentan'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-27', 'studyFirstSubmitDate': '2011-01-04', 'studyFirstSubmitQcDate': '2011-01-04', 'lastUpdatePostDateStruct': {'date': '2011-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SIX MINUTE WALKING DISTANCE', 'timeFrame': 'SIX MONTHS', 'description': 'CHANGE IN SIX MINUTE WALKING DISTANCE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.'}, {'measure': 'MAXIMAL OXYGEN UPTAKE', 'timeFrame': '6 MONTHS', 'description': 'CHANGE IN MAXIMAL OXYGEN UPTAKE AFTER 6 MONTHS OF THERAPY COMPARED TO PRE-TREATMENT VALUE.'}], 'secondaryOutcomes': [{'measure': 'ECHOCARDIOGRAPHIC PULMONARY PRESSURE', 'timeFrame': '6 MONTHS', 'description': 'ECHOCARDIOGRAPHIC ASSESSMENT OF PEAK AND MEAN PULMONARY PRESSURE AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.'}, {'measure': 'ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION', 'timeFrame': '6 MONTHS', 'description': 'ECHOCARDIOGRAPHIC ASSESSMENT OF LEFT VENTRICULAR FUNCTION AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.'}, {'measure': 'SERUM PRO-BNP', 'timeFrame': '6 MONTHS', 'description': 'ASSESSMENT OF SERUM PRO-BRAIN NATRIURETIC PEPTIDE LEVELS AT 6 MONTHS AFTER TREATMENT COMPARED WITH PRE-TREATMENT VALUES.'}, {'measure': 'DYSPNEA', 'timeFrame': '6 MONTHS', 'description': 'CHANGE IN BORG DYSPNEA INDEX COMPARED WITH PRE-TREATMENT VALUES.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ENDOTHELIN RECEPTOR ANTAGONIST', 'BOSENTAN', 'SECONDARY PULMONARY HYPERTENSION', 'RHEUMATOID FEVER', 'CONGESTIVE HEART FAILURE', 'SECONDARY PULMONARY HYPERTENSION DUE TO MITRAL STENOSIS'], 'conditions': ['SECONDARY PULMONARY HYPERTENSION', 'MITRAL STENOSIS', 'CHILDHOOD RHEUMATOID FEVER', 'CONGESTIVE HEART FAILURE']}, 'descriptionModule': {'briefSummary': 'Vasoconstrictive signaling via endothelin receptors is not limited to primary pulmonary arterial hypertension, but has also been documented in secondary pulmonary hypertension due to congestive heart failure, including cardiac valve disease. The investigators aim to examine the clinical and physiologic effects of bosentan therapy in patients with secondary pulmonary hypertension due to severe, inoperable cardiac valve disease, using a single-center, prospective, open-label, non-randomized study of oral bosentan in outpatients with severe mitral stenosis due to childhood rheumatoid fever. Primary end-point will be exercise capacity at six months determined by six-minute walking distance and cardiopulmonary exercise testing. Secondary end-points will be symptomatic relief, echocardiographic left ventricular function and pulmonary pressure, serum pro-brain natriuretic peptide, and adverse events at six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatient\n* \\> 60 Yrs Old\n* \\< 85 Yrs Old\n* Stable disease\n* Congestive heart failure NYHA IIIB/V\n* Inoperable mitral stenosis due to childhood rheumatoid fever\n* Mean pulmonary artery pressure \\> 40 cm H2O\n\nExclusion Criteria:\n\n* Prior treatment with endothelin receptor antagonist(s)\n* Hospitalization (exacerbation)\n* Cardiac valve surgery'}, 'identificationModule': {'nctId': 'NCT01270750', 'acronym': 'BOSMIVAR', 'briefTitle': 'Bosentan for Severe Mitral Valve Dysfunction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'General Hospital of Chalkida'}, 'officialTitle': 'Pilot Trial of Bosentan for Secondary Pulmonary Hypertension Due to Severe Mitral Valve Dysfunction', 'orgStudyIdInfo': {'id': 'GHC2/29/22-09-2008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BOSENTAN', 'type': 'DRUG', 'description': 'TWICE DAILY PERORAL BOSENTAN, 125 MG DAILY DIVIDED IN TWO DOSES DURING THE FIRST MONTH AND 250 MG DAILY DIVIDED IN TWO DOSES SUBSEQUENTLY.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34100', 'city': 'Chalcis', 'state': 'Evoia', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'GEORGE VLACHOGIORGOS, MD PHD', 'role': 'CONTACT', 'email': 'georgevlacho@gmail.com', 'phone': '00306936192419'}, {'name': 'GEORGE VLACHOGIORGOS, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'General Hospital of Chalkida', 'geoPoint': {'lat': 38.46354, 'lon': 23.60284}}], 'centralContacts': [{'name': 'GEORGE VLACHOGIORGOS, MD PHD', 'role': 'CONTACT', 'email': 'georgevlacho@gmail.com', 'phone': '00306936192419'}], 'overallOfficials': [{'name': 'GEORGE VLACHOGIORGOS, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GENERAL HOSPITAL OF CHALKIDA, GREECE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Chalkida', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'GEORGE VLACHOGIORGOS', 'oldOrganization': 'General Hospital of Chalkida'}}}}