Inflammation Clinical Trial
Official title:
Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease: Prospective, Randomized, Controlled Study
This prospective, randomized, controlled study aims to investigate the effects of atorvastatin treatment in hemodialysis patients concerning progression of coronary artery calcification, progression of carotid artery intima-media thickness, endothelial function, and inflammation.
The effects of statin treatment on coronary artery calcifications, carotid artery
intima-media thickness, and endothelial functions have never been investigated in
hemodialysis patients. Regarding inflammation, the present data in hemodialysis patients are
derived from small studies with short follow-up.
We postulate that atorvastatin would reduce progression of coronary calcification and
carotid artery intima-media thickness, decrease inflammation, and improve endothelial
function.
In this prospective, controlled, randomized study, four hundred forty-six prevalent
hemodialysis patients who meet inclusion and exclusion criteria will be randomized to
atorvastatin (20 mg/day in first month; increased to 40 mg/day afterwards) and placebo arms
(each arm consists of 223 patients), after completion of baseline investigations.
Randomization will be performed with random permuted blocks and will be stratified according
to dialysis center, age, sex, diabetic status, duration of dialysis, high flux dialyser use,
and dialysate calcium level. Follow-up period will be twelve months.
It is estimated that 446 patients would provide 90% power with a two-sided, alpha error rate
of 5%, of detecting a significant difference between treatment arms. Dropout rate is
expected to be 20%, not to be replaced.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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