Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination
- Conditions
- Atherosclerosis
- Interventions
- Drug: placebo
- Registration Number
- NCT03393377
- Lead Sponsor
- University Medical Centre Ljubljana
- 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 fluvastatin/valsartan combination (low-flu/val).
Twenty males at moderate cardiovascular risk (as classified by SCORE) were blindly randomised into the intervention group (n=10, low-flu/val: 10 mg/20mg) or control group (n=10, 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
- moderate cardiovascular risk according to Systematic Coronary Risk Estimation (SCORE) risk charts of the European Society of Cardiology
- males
- aged between 40 and 55 years
- diabetes mellitus
- manifest peripheral artery disease or carotid artery disease
- acute infection
- chronic diseases
- present therapy with fluvastatin and/or valsartan
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group fluvastatin 10 mg and valsartan 20 mg received fluvastatin 10 mg and valsartan 20 mg (low-flu/val) for 30 days control group placebo received placebo for 30 days
- Primary Outcome Measures
Name Time Method gene Nrf2/NFE2L2 30 days Hs00975961_g1
gene AMPK/PRKAA1 30 days Hs01562315_m1
brachial flow-mediated dilatation (FMD) 30 days FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia)
reactive hyperaemia index (RHI) 30 days RHI measured by Endopat device
gene mTOR 30 days Hs00234522_m1
vascular cell adhesion molecule 1 (VCAM1) 30 days inflammatory marker
beta stiffness coefficient 30 days assessed by ultrasound employing e-Tracking on right common carotid artery
gene NF-kB1 30 days Hs00765730_m1
carotid pulse wave velocity (c-PWV) 30 days assessed by ultrasound employing e-Tracking on right common carotid artery
carotid-femoral PWV (cf-PWV) 30 days cf-PWV measured by Sphygmocor device
high-sensitivity C-reactive protein (hs-CRP) 30 days inflammatory marker
interleukin 6 (IL-6) 30 days inflammatory marker
total antioxidant status (TAS) 30 days marker of oxidative stress
gene SIRT1 30 days Hs01009006_m1
- Secondary Outcome Measures
Name Time Method brachial flow-mediated dilatation (FMD) 10 weeks after treatment completion FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia)
reactive hyperaemia index (RHI) 10 weeks after treatment completion RHI measured by Endopat device
beta stiffness coefficient 10 weeks after treatment completion assessed by ultrasound employing e-Tracking on right common carotid artery
carotid pulse wave velocity (c-PWV) 10 weeks after treatment completion assessed by ultrasound employing e-Tracking on right common carotid artery
carotid-femoral PWV (cf-PWV) 10 weeks after treatment completion cf-PWV measured by Sphygmocor device