Hypercholesterolemia, Hypertension
Conditions
Keywords
essential hypertension
Brief summary
To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond those on lipid profile. Glycemic parameters, novel cardiovascular risk factors and safety parameters will be also evaluated.
Interventions
DRUGAtorvastatin
10 mg of atorvastatin once daily for six months
DRUGPlacebo
placebo once daily for six months
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* LDL-C\>130 or \>160 mg/dL (depending on the total risk according to the most recent recommendations25). * no previous hypolipidemic medication * ability to provide Informed Consent.
Exclusion criteria
* pregnancy or lactation * myocardial infarction or unstable angina within the past 6 months * heart failure NYHA class III-IV * renal disease (SCr\>3 mg/dL or proteinuria\>3g/d) * liver disease * history of malignancy * history of drug or alcohol abuse * treatment with corticosteroids * any other condition with poor prognosis * inability to provide Informed Consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ambulatory blood pressure | Six months |
Secondary
| Measure | Time frame |
|---|---|
| Insulin Sensitivity | Six months |
| Arterial Stiffness | Six months |
| Urinary levels of nephrin | Six months |
| Urinary Albumin Excretion | Six months |
| Urinary levels of Endothelin-1 | Six months |
| Urinary levels of Asymmetric Dimethylarginine | Six months |
| Urinary levels of indices of oxidative stress | Six months |
| Urinary levels of podocalyxin | Six months |
Countries
Greece
Outcome results
None listed