Kawasaki Disease Clinical Trial
Official title:
Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease
The purpose of this study is to determine whether Chilean children with history of Kawasaki disease have endothelial dysfunction years after the acute phase of the disease, and if this condition can be modified by treatment with statins.
Kawasaki disease (KD) in its acute phase produces endothelial inflammation that can lead to
dilatation and aneurysms of coronary and peripheral arteries. This initial injury leads to
persistent endothelial dysfunction several years after having the disease. As a consequence,
these patients may have a higher cardiovascular risk than general population. Studies with
HMG-CoA reductase inhibitors (statins) have suggested that these have an anti-inflammatory
effect over the endothelium, that may be independent of its lipid-lowering effects. The
hypothesis of this study is that KD produces endothelial dysfunction that is persistent
years after acute disease, and that this dysfunction can be modified by treatment with
statins.The study consists of two phases. On the first we will perform ultrasound assessment
of endothelial-dependent flow-mediated vasodilation of the brachial artery and evaluate
other cardiovascular risk markers in patients and healthy controls. On the second phase
patients with history of Kawasaki disease will be randomized and allocated to treatment with
Pravastatin or placebo, after which a new evaluation of flow-mediated dilation of the
brachial artery and cardiovascular risk markers will be performed.
Comparison(s): Children older than 8 years of age with history of Kawasaki disease more than
12 months before enrollment, compared with paired by age children without history of KD or
other cardiovascular risk factors.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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