Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051389
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2003-01-09
Brief Title:
ACE Inhibition and Novel Cardiovascular Risk Factors
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
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:
To determine the effects of an angiotensin converting enzyme inhibitor ACE inhibitor fosinopril on multiple blood markers in 286 adults at high risk for cardiovascular disease
Detailed Description:
BACKGROUND
Angiotensin converting enzyme inhibitors ACE inhibitors may prevent cardiovascular events in high risk persons and improve skeletal muscle function in heart failure patients by means of mechanisms that are independent of blood pressure changes However there is limited knowledge of all the mechanisms underlying the therapeutic benefits of ACE inhibition ACE inhibitors may favorably modify markers of fibrinolysis inflammation endothelial function and extracellular tissue remodeling all of which are associated with atherosclerosis and cardiovascular disease But clinical trial evidence on these effects is limited In addition polymorphisms of the ACE angiotensinogen PAI-1 and IL-6 genes may modify the therapeutic response to ACE inhibitors
DESIGN NARRATIVE
This was a double-blind cross-over randomized placebo controlled trial in 286 persons with high cardiovascular risk to compare the effects of 6 months of treatment with fosinopril and 6 months with placebo on the following primary outcomes plasma plasminogen activator inhibitor-1 PAI-1 antigen C- reactive protein CRP interleukin-6 IL-6 and soluble vascular cell adhesion molecule-1 sVCAM-1 The secondary objectives were a to assess the effects of fosinopril on IL-6IL-6 Soluble Receptor ratio PAI-1 activity tissue plasminogen activator TPA antigen fibrinogen endothelin-1 TNF-alpha soluble intercellular cell adhesion molecule-1 sICAM-1 E-selectin matrix metalloproteinase-1 MMP-1 and tissue inhibitor of metalloproteinase-1 TIMP-1 and b to explore the effects of ACE angiotensinogen PAI-1 and IL-6 gene polymorphisms on these biomarkers and test the interaction of the gene polymorphisms with the effects of fosinopril The study had sufficient power to detect small changes in several biomarkers compared to placebo The assessment of these biological mechanisms had clinical relevance for identifying the patients who may benefit the most from ACE inhibition While the focus of the study was on novel cardiovascular risk factors the results may also have future implications for developing new indications for ACE inhibitors such as for example the prevention of age-related muscle wasting and physical disabilities in older persons for which inflammation may be a causal factor
Angiotensin converting enzyme inhibitors ACE inhibitors may prevent cardiovascular events in high risk persons and improve skeletal muscle function in heart failure patients by means of mechanisms that are independent of blood pressure changes However there is limited knowledge of all the mechanisms underlying the therapeutic benefits of ACE inhibition ACE inhibitors may favorably modify markers of fibrinolysis inflammation endothelial function and extracellular tissue remodeling all of which are associated with atherosclerosis and cardiovascular disease But clinical trial evidence on these effects is limited In addition polymorphisms of the ACE angiotensinogen PAI-1 and IL-6 genes may modify the therapeutic response to ACE inhibitors
DESIGN NARRATIVE
This was a double-blind cross-over randomized placebo controlled trial in 286 persons with high cardiovascular risk to compare the effects of 6 months of treatment with fosinopril and 6 months with placebo on the following primary outcomes plasma plasminogen activator inhibitor-1 PAI-1 antigen C- reactive protein CRP interleukin-6 IL-6 and soluble vascular cell adhesion molecule-1 sVCAM-1 The secondary objectives were a to assess the effects of fosinopril on IL-6IL-6 Soluble Receptor ratio PAI-1 activity tissue plasminogen activator TPA antigen fibrinogen endothelin-1 TNF-alpha soluble intercellular cell adhesion molecule-1 sICAM-1 E-selectin matrix metalloproteinase-1 MMP-1 and tissue inhibitor of metalloproteinase-1 TIMP-1 and b to explore the effects of ACE angiotensinogen PAI-1 and IL-6 gene polymorphisms on these biomarkers and test the interaction of the gene polymorphisms with the effects of fosinopril The study had sufficient power to detect small changes in several biomarkers compared to placebo The assessment of these biological mechanisms had clinical relevance for identifying the patients who may benefit the most from ACE inhibition While the focus of the study was on novel cardiovascular risk factors the results may also have future implications for developing new indications for ACE inhibitors such as for example the prevention of age-related muscle wasting and physical disabilities in older persons for which inflammation may be a causal factor
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL068901 | NIH | None | httpsreporternihgovquickSearchR01HL068901 |