Ignite Creation Date:
2024-05-06 @ 9:24 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02970851
Status:
TERMINATED
Last Update Posted:
2020-03-23
First Post:
2016-06-19
Brief Title:
Bosentan in Myocardium Metabolism and Perfusion Measured by 18F-FDG and 82Rb PETCT on PAH and CTEPH
Sponsor:
University of Lausanne Hospitals
Organization:
University of Lausanne Hospitals
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow patient recruitment after arrival of macitentan on the market
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Hypothesis 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
Hypothesis 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
Detailed Description:
Patients refered to the hospital for a right heart catheterization for a PAH suspected at the echocardiography will be presented with the protocolIf inclusionexclusion 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 PETCTs before start of treatment with Bosentan These PETCTs together with an echocardiography will be repeated at 6 and 12 weeks after start of treatment with bosentan
Finally a right heart catheterization will be planned at 12 weeks after start of treatment with bosentan as a routine procedure
Finally a right heart catheterization will be planned at 12 weeks after start of treatment with bosentan as a routine procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None