Trials / Completed
CompletedNCT03393377
Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination
Preventive Arterial Wall Phenotype in Subjects at Moderate Cardiovascular Risk Induced by Very Low-dose Fluvastatin/Valsartan Combination: a Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University Medical Centre Ljubljana · Academic / Other
- Sex
- Male
- Age
- 40 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | fluvastatin 10 mg and valsartan 20 mg | |
| DRUG | placebo |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2015-06-01
- Completion
- 2017-06-01
- First posted
- 2018-01-08
- Last updated
- 2018-01-08
Source: ClinicalTrials.gov record NCT03393377. Inclusion in this directory is not an endorsement.