fluvastatin 10 mg and valsartan 20 mg
DrugOther names: low-flu/val
NCT Number: NCT03393377
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.
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Notify Me40 year–55 year
Male
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: low-flu/val
Time frame: 30 days
FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia)
Time frame: 30 days
RHI measured by Endopat device
Time frame: 30 days
assessed by ultrasound employing e-Tracking on right common carotid artery
Time frame: 30 days
assessed by ultrasound employing e-Tracking on right common carotid artery
Time frame: 30 days
cf-PWV measured by Sphygmocor device
Time frame: 30 days
inflammatory marker
Time frame: 30 days
inflammatory marker
Time frame: 30 days
inflammatory marker
Time frame: 30 days
marker of oxidative stress
Time frame: 30 days
Hs01009006_m1
Time frame: 30 days
Hs00234522_m1
Time frame: 30 days
Hs00765730_m1
Time frame: 30 days
Hs00975961_g1
Time frame: 30 days
Hs01562315_m1
Time frame: 10 weeks after treatment completion
FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia)
Time frame: 10 weeks after treatment completion
RHI measured by Endopat device
Time frame: 10 weeks after treatment completion
assessed by ultrasound employing e-Tracking on right common carotid artery
Time frame: 10 weeks after treatment completion
assessed by ultrasound employing e-Tracking on right common carotid artery
Time frame: 10 weeks after treatment completion
cf-PWV measured by Sphygmocor device
University Medical Centre Ljubljana
Other
Preventive Arterial Wall Phenotype in Subjects at Moderate Cardiovascular Risk Induced by Very Low-dose Fluvastatin/Valsartan Combination: a Pilot Study
Acronym: AGE-ZT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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