Ignite Creation Date:
2024-05-06 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03393377
Status:
COMPLETED
Last Update Posted:
2018-01-08
First Post:
2017-12-29
Brief Title:
Preventive Arterial Wall Phenotype and Low-dose FluvastatinValsartan Combination
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
Preventive Arterial Wall Phenotype in Subjects at Moderate Cardiovascular Risk Induced by Very Low-dose FluvastatinValsartan Combination a Pilot Study
Status:
COMPLETED
Status Verified Date:
2018-01
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:
AGE-ZT
Brief Summary:
The study was designed to test whether short-term treatment with a very low-dose combination of fluvastatin and valsartan could induce improvement of endothelial function arterial stiffness vascular inflammation oxidative stress and expression of protective genes in subjects with moderate cardiovascular risk
Detailed Description:
The largest population that suffers from cardiovascular events are subjects at moderate cardiovascular risk However no effective and safe preventive treatment is available for this population This study aimed to investigate whether their arterial wall phenotype could be turned to a preventive direction by low-dose fluvastatinvalsartan combination low-fluval
Twenty males at moderate cardiovascular risk as classified by SCORE were blindly randomised into the intervention group n10 low-fluval 10 mg20mg or control group n10 placebo At inclusion and after 30 days of treatment brachial flow-mediated dilatation FMD beta stiffness coefficient carotid pulse wave velocity c-PWV carotid-femoral PWV reactive hyperaemia index high-sensitivity C-reactive protein hs-CRP interleukin 6 vascular cell adhesion molecule 1 total antioxidant status and expression of several protective genes SIRT1 mTOR NF-κB1 NFE2L2 PRKAA1 were followed
Twenty males at moderate cardiovascular risk as classified by SCORE were blindly randomised into the intervention group n10 low-fluval 10 mg20mg or control group n10 placebo At inclusion and after 30 days of treatment brachial flow-mediated dilatation FMD beta stiffness coefficient carotid pulse wave velocity c-PWV carotid-femoral PWV reactive hyperaemia index high-sensitivity C-reactive protein hs-CRP interleukin 6 vascular cell adhesion molecule 1 total antioxidant status and expression of several protective genes SIRT1 mTOR NF-κB1 NFE2L2 PRKAA1 were followed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None