Cardiovascular Disease, Endothelial Dysfunction
Conditions
Keywords
endothelial function, flow mediated dilatation, rosuvastatin, folic acid, B vitamins
Brief summary
Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.
Detailed description
Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.
Interventions
DRUGfolic acid, vitamin B12 and B6 and rosuvastatin
Vitamin supplementation with folic acid 1mg/d, vitamin B12 0.4mg/d and B6 10mg/d po for 6 weeks alone vs. rosuvastatin 10mg/d for 6 weeks alone and thereafter combined treatment for 6 weeks
Sponsors
Insel Gruppe AG, University Hospital Bern
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 No maximum
Healthy volunteers
No
Inclusion criteria
* CAD or PAD (\>50% luminal stenosis), previous myocardial infarction or bypass surgery \>3 month ago * history of percutaneous coronary intervention (PTCA or stenting) * confirmed consent
Exclusion criteria
* myocardial infarction or acute coronary syndrome or bypass surgery \<3 month ago * ongoing treatment with statins * ongoing vitamin supplementation with folic acid and B vitamins * \<18 years * active smokers * uncontrolled arterial hypertension * renal insufficiency * atrial fibrillation * liver disease * NYHA class \>2 * familial hypercholesterolemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow mediated dilatation (FMD) | after 6 weeks of randomized treatment and after 6 weeks of combined treatment |
Secondary
| Measure | Time frame |
|---|---|
| changes in biochemistry parameters | after 6 weeks of randomized treatment and after 6 weeks of combined treatment |
Outcome results
None listed