Hypertension
Conditions
Brief summary
Few trials have investigated the hypotensive effect of the Statins. Most were not specifically aimed at this pleiotropic effect or had methodological problems. The possible hypotensive effect may explain part of the favorable results of the Statins use on cardiovascular prevention independently from its action on the cholesterol profile. The purpose of this study is to determine the effect of Simvastatin on the blood pressure
Detailed description
This is a randomized double blind parallel clinical trial where hypertensive patients with controlled or uncontrolled blood pressure and without evidence of target-organ damage will be selected. Subjects will receive Simvastatin 40 mg once daily or placebo and a baseline and eight weeks ABPM will performed. The main outcome will be the difference in systolic BP in the 24h-ABPM.
Interventions
DRUGSimvastatin 40mg
Simvastatin once daily, orally in the morning period, during eigth weeks
DRUGPlacebo
Placebo once daily, orally in the morning period, during eigth weeks
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Hypertensive patients with controlled or uncontrolled blood pressure
Exclusion criteria
* Secondary causes of hypertension; * Systolic Blood pressure \>= 180 mmHg and/or diastolic blood pressure \>= 110 mmHg * Complain of side effects related to Statins * Diabetes * Established target-organ damage (myocardial infarction, stroke, angina, heart failure, peripheral vascular disease) * Renal disease (creatinine \> 1,5 mgdl).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM) | Eigth weeks |
Countries
Brazil
Contacts
Primary ContactMiguel Gus, MD
Outcome results
None listed