Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT02970851
Status:
TERMINATED
Last Update Posted:
2020-03-23
First Post:
2016-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bosentan in Myocardium Metabolism and Perfusion Measured by 18F-FDG and 82Rb PET/CT on PAH and CTEPH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065627', 'term': 'Familial Primary Pulmonary Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Slow patient recruitment after arrival of macitentan on the market', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-18', 'studyFirstSubmitDate': '2016-06-19', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of each method of imaging for assessment of myocardial metabolism', 'timeFrame': 'Baseline', 'description': 'On the images of au 18F-FDG PET/CT : myocardial ventricular right maximum standardized uptake value (SUVmax)'}, {'measure': 'Analysis of each method of imaging for assessment of myocardial metabolism', 'timeFrame': 'at 4 weeks after start of treatment', 'description': 'myocardial ventricular right maximum standardized uptake value (SUVmax) on the images of au 18F-FDG PET/CT'}, {'measure': 'Analysis of each method of imaging for assessment of myocardial metabolism', 'timeFrame': 'at 6 weeks after start of treatment', 'description': 'On the images of au 18F-FDG PET/CT : myocardial ventricular right maximum standardized uptake value (SUVmax)'}, {'measure': 'Analysis of each method of imaging for assessment of myocardial metabolism', 'timeFrame': 'at 12 weeks after start of treatment', 'description': 'On the images of au 18F-FDG PET/CT : myocardial ventricular right maximum standardized uptake value (SUVmax)'}, {'measure': 'On the images 82Rb PET/CT rest MBF', 'timeFrame': 'Baseline', 'description': 'myocardial blood flow (MBF in mL/min/g) at rest'}, {'measure': 'On the images 82Rb PET/CT rest MBF', 'timeFrame': 'at 4 weeks after start of treatment', 'description': 'myocardial blood flow (MBF in mL/min/g) at rest'}, {'measure': 'On the images 82Rb PET/CT rest MBF', 'timeFrame': 'at 6 weeks after start of treatment', 'description': 'myocardial blood flow (MBF in mL/min/g) at rest'}, {'measure': 'On the images 82Rb PET/CT rest MBF', 'timeFrame': 'at 12 weeks after start of treatment', 'description': 'myocardial blood flow (MBF in mL/min/g) at rest'}, {'measure': 'On the images 82Rb PET/CT stress MBF', 'timeFrame': 'Baseline', 'description': 'myocardial blood flow (MBF in mL/min/g) at pharmacological stress'}, {'measure': 'On the images 82Rb PET/CT stress MBF', 'timeFrame': 'at 4 weeks after start of treatment', 'description': 'myocardial blood flow (MBF in mL/min/g) at pharmacological stress'}, {'measure': 'On the images 82Rb PET/CT stress MBF', 'timeFrame': 'at 6 weeks after start of treatment', 'description': 'myocardial blood flow (MBF in mL/min/g) at pharmacological stress'}, {'measure': 'On the images 82Rb PET/CT stress MBF', 'timeFrame': 'at 12 weeks after start of treatment', 'description': 'myocardial blood flow (MBF in mL/min/g) at pharmacological stress'}, {'measure': 'On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF', 'timeFrame': 'Baseline', 'description': 'myocardial blood flow (MBF in mL/min/g) at cold test'}, {'measure': 'On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF', 'timeFrame': 'at 4 weeks after start of treatment', 'description': 'myocardial blood flow (MBF in mL/min/g) at cold test'}, {'measure': 'On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF', 'timeFrame': 'at 6 weeks after start of treatment', 'description': 'myocardial blood flow (MBF in mL/min/g) at cold test'}, {'measure': 'On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF', 'timeFrame': 'at 12 weeks after start of treatment', 'description': 'myocardial blood flow (MBF in mL/min/g) at cold test'}, {'measure': 'Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction', 'timeFrame': 'Baseline', 'description': 'On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)'}, {'measure': 'Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction', 'timeFrame': 'at 4 weeks after start of treatment', 'description': 'On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)'}, {'measure': 'Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction', 'timeFrame': 'at 6 weeks after start of treatment', 'description': 'On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)'}, {'measure': 'Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction', 'timeFrame': 'at 12 weeks after start of treatment', 'description': 'On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)'}], 'secondaryOutcomes': [{'measure': 'Analysis of right heart catheterization parameters PAP', 'timeFrame': 'at screening', 'description': 'pulmonary arterial pressure (PAP)'}, {'measure': 'Analysis of right heart catheterization parameters PAP', 'timeFrame': 'at 12 weeks after start of treatment', 'description': 'PAP'}, {'measure': 'Analysis of right heart catheterization parameters RAP', 'timeFrame': 'at screening', 'description': 'right atrial pressure (RAP)'}, {'measure': 'Analysis of right heart catheterization parameters RAP', 'timeFrame': 'at 12 weeks after start of treatment', 'description': 'RAP'}, {'measure': 'Analysis of right heart catheterization parameters PWP', 'timeFrame': 'at screening', 'description': 'pulmonary wedge pressure (PWP)'}, {'measure': 'Analysis of right heart catheterization parameters PWP', 'timeFrame': 'at 12 weeks after start of treatment', 'description': 'PWP'}, {'measure': 'Analysis of clinical parameters NYHA', 'timeFrame': 'at screening', 'description': 'NYHA classification'}, {'measure': 'Analysis of clinical parameters NYHA', 'timeFrame': 'at 12 weeks after start of treatment', 'description': 'New York Heart Association (NYHA) classification'}, {'measure': 'Analysis of clinical parameters 6-min walk test', 'timeFrame': 'at screening', 'description': '6-minute walk test'}, {'measure': 'Analysis of clinical parameters 6-min walk test', 'timeFrame': 'at 12 weeks after start of treatment', 'description': '6-minute walk test'}, {'measure': 'Analysis of clinical parameters LFT', 'timeFrame': 'at screening', 'description': 'Results of lung function tests'}, {'measure': 'Analysis of clinical parameters LFT', 'timeFrame': 'at 12 weeks after start of treatment', 'description': 'Results of lung function tests'}, {'measure': 'Analysis of clinical parameters NT-pro-BNP', 'timeFrame': 'at screening', 'description': 'plasmatic N terminal - pro - Brain Natriuretic Peptide (NT-pro-BNP)'}, {'measure': 'Analysis of clinical parameters NT-pro-BNP', 'timeFrame': 'at 12 weeks after start of treatment', 'description': 'plasmatic NT-pro-BNP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endothelin receptor antagonist (ERA)', 'pulmonary artery hypertension (PAH),', '18F-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT', 'Rubidium-82 (82Rb) PET/CT'], 'conditions': ['Myocardial Dysfunction', 'Endothelial Dysfunction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://erj.ersjournals.com/content/50/suppl_61/PA2414', 'label': 'abstract poster presentation about present study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of bosentan on the myocardial metabolism and the dependent endothelial coronary vasomotoricity in patients presenting a PAH.\n\nHypothesis : Bosentan may improve right ventricular function by decreasing myocardial stress and glucose metabolism. Patients may benefit from images with 18F-FDG PET / CT and 82Rb PET / CT for an earlier assessment and optimal management of PAH.', 'detailedDescription': 'Patients refered to the hospital for a right heart catheterization for a PAH suspected at the echocardiography will be presented with the protocol.If inclusion/exclusion criteria are fulfilled all the procedures will be planned. At the screening visit the patient will have a right heart catheterization and an echocardiography. After a maximum of 4 weeks each patient will have 18F-FDG and 82Rb PET/CTs before start of treatment with Bosentan. These PET/CTs together with an echocardiography will be repeated at 6 and 12 weeks after start of treatment with bosentan.\n\nFinally a right heart catheterization will be planned at 12 weeks after start of treatment with bosentan as a routine procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients eligible for Bosentan therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic PAH (PH group 1 Dana Point / stages 2 à 4 according to NYHA classification, defined by a mean arterial pulmonary pressure \\>25 millimeter of mercury (mmHg) at rest, an occlusion arterial pulmonary pressure \\<15 millimeter of mercury (mmHg) and vascular pulmonary resistance \\>240 dyn.s.cm-5 for which a treatment with bosentan is indicated Or Patients with CTEPH not candidate for a pulmonary endarterectomy or patient with residual CTEPH after pulmonary endarterectomy (PH group 4 Dana Point / stages 2 to 4 according to NYHA classification) and for which a treatment with bosentan is indicated\n* Indication to perform a right heart catheterization in the context of PAH suspected during cardiac ultrasound\n* Age from 18 to 80 years old, male and female\n* Karnofsky index ≥80%\n* Informed consent signed\n\nExclusion Criteria:\n\n* Patients with PAH stages 2,3 or 5 of Dana Point\n* Patients with a contra-indication to adenosine including severe uncontrolled asthma, severe uncontrolled chronic obstructive pulmonary disease, 2nd or 3rd degree atrioventricular block without pacemaker,\n* Patients with a contraindication to Bosentan, i.e :hypersensibility to the product, hepatic failure Child Pugh B or C, aminotransferases \\>3 times normal value (N),association with cyclosporine A or glibenclamide\n* Pregnancy, female of child-bearing potential not using any acceptable contraceptive method, breastfeeding\n* Atrial fibrillation (Ventricular Ejection Fraction (VEF) not evaluable at echography)\n* Karnofsky index \\<80%\n* Impossibility to obtain informed consent signed\n* Left cardiopathies that can be responsible of post-capillar hypertension\n* Involvement in another clinical study with an unregistered drug within 30 days prior to this specific study and during the entire course of the study\n* Inability to comply with study procedures (linguistic problem, psychiatric problems, dementia, confusional state)\n* Known or suspected non compliance drug or alcohol abuse\n* Left heart assessment : diastolic and systolic function and valvular structures to exclude a cardiac pathology'}, 'identificationModule': {'nctId': 'NCT02970851', 'briefTitle': 'Bosentan in Myocardium Metabolism and Perfusion Measured by 18F-FDG and 82Rb PET/CT on PAH and CTEPH', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Effect of Endothelin Receptor Antagonist Bosentan in Glucose Metabolism of the Myocardium and Coronary Dependant Endothelial Vasoreactivity Measured by 18F-FDG PET / CT and 82Rb PET / CT in Patients With PAH or CTEPH', 'orgStudyIdInfo': {'id': '08/12'}}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'John O Prior, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lausanne University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of the Department of Nuclear medicine', 'investigatorFullName': 'John O. Prior', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}