Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180713
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2005-09-12
Brief Title:
Simvastatin as a Treatment for Pulmonary Hypertension
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Simvastatin as a Treatment for Pulmonary Hypertension
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to investigate the safety and efficacy of adding simvastatin to the current conventional treatment regimen for the management of pulmonary hypertension
Detailed Description:
Pulmonary arterial hypertension PAH is a disease that is characterised by progressive narrowing of the blood vessels of the lungs This results in a pressure load on the heart and heart failure
The narrowing is in part due to constriction but mostly due to structural changes in affected vessels The structural changes affect all cell components of the vessel wall the endothelial lining the muscle layer and fibrous tissue and can lead to local clot formation In addition there is evidence of inflammation of the vessels and what is known as oxidative stress The disease may occur with no obvious cause when it is known as idiopathic but it can also be associated with a variety of other diseases including congenital heart disease collagen vascular disease and HIV infection
Current approaches to the treatment of pulmonary hypertension are unsatisfactory as they do not prevent disease progression and do not directly or adequately address many of the processes detailed above Alternative or additional treatments are therefore required and an attrative approach is to use a statin a 3-hydroxy-3-methylglutaryl-coenzymeA or HMG-CoA reductase inhibitor Statins are widely used for their ability to lower blood cholesterol but increasing evidence indicates that these drugs also have direct effects on cell components of the vessel wall - including inhibiting inflammation clot formation and oxidative stress - that might be beneficial in pulmonary hypertension
The narrowing is in part due to constriction but mostly due to structural changes in affected vessels The structural changes affect all cell components of the vessel wall the endothelial lining the muscle layer and fibrous tissue and can lead to local clot formation In addition there is evidence of inflammation of the vessels and what is known as oxidative stress The disease may occur with no obvious cause when it is known as idiopathic but it can also be associated with a variety of other diseases including congenital heart disease collagen vascular disease and HIV infection
Current approaches to the treatment of pulmonary hypertension are unsatisfactory as they do not prevent disease progression and do not directly or adequately address many of the processes detailed above Alternative or additional treatments are therefore required and an attrative approach is to use a statin a 3-hydroxy-3-methylglutaryl-coenzymeA or HMG-CoA reductase inhibitor Statins are widely used for their ability to lower blood cholesterol but increasing evidence indicates that these drugs also have direct effects on cell components of the vessel wall - including inhibiting inflammation clot formation and oxidative stress - that might be beneficial in pulmonary hypertension
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