Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination (AGE-ZT)

University Medical Centre Ljubljana

Status: Completed

Conditions: Atherosclerosis

Treatments: Drug: fluvastatin 10 mg and valsartan 20 mg; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03393377

AGE-ZT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• diabetes mellitus
• manifest peripheral artery disease or carotid artery disease
• acute infection
• chronic diseases
• present therapy with fluvastatin and/or valsartan

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

20 participants in 2 patient groups, including a placebo group

intervention group

Experimental group

Description:

received fluvastatin 10 mg and valsartan 20 mg (low-flu/val) for 30 days

Treatment:

Drug: fluvastatin 10 mg and valsartan 20 mg

control group

Placebo Comparator group

Description:

received placebo for 30 days

Treatment:

Drug: placebo