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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
20
brachial flow-mediated dilatation (FMD)
FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia)
Time frame: 30 days
reactive hyperaemia index (RHI)
RHI measured by Endopat device
Time frame: 30 days
beta stiffness coefficient
assessed by ultrasound employing e-Tracking on right common carotid artery
Time frame: 30 days
carotid pulse wave velocity (c-PWV)
assessed by ultrasound employing e-Tracking on right common carotid artery
Time frame: 30 days
carotid-femoral PWV (cf-PWV)
cf-PWV measured by Sphygmocor device
Time frame: 30 days
high-sensitivity C-reactive protein (hs-CRP)
inflammatory marker
Time frame: 30 days
interleukin 6 (IL-6)
inflammatory marker
Time frame: 30 days
vascular cell adhesion molecule 1 (VCAM1)
inflammatory marker
Time frame: 30 days
total antioxidant status (TAS)
marker of oxidative stress
Time frame: 30 days
gene SIRT1
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Hs01009006\_m1
Time frame: 30 days
gene mTOR
Hs00234522\_m1
Time frame: 30 days
gene NF-kB1
Hs00765730\_m1
Time frame: 30 days
gene Nrf2/NFE2L2
Hs00975961\_g1
Time frame: 30 days
gene AMPK/PRKAA1
Hs01562315\_m1
Time frame: 30 days
brachial flow-mediated dilatation (FMD)
FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia)
Time frame: 10 weeks after treatment completion
reactive hyperaemia index (RHI)
RHI measured by Endopat device
Time frame: 10 weeks after treatment completion
beta stiffness coefficient
assessed by ultrasound employing e-Tracking on right common carotid artery
Time frame: 10 weeks after treatment completion
carotid pulse wave velocity (c-PWV)
assessed by ultrasound employing e-Tracking on right common carotid artery
Time frame: 10 weeks after treatment completion
carotid-femoral PWV (cf-PWV)
cf-PWV measured by Sphygmocor device
Time frame: 10 weeks after treatment completion