Cardiovascular Risk Markers and Response to Statins After 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease|
- Percent of change in brachial artery dilatation after statin therapy
- Decrease in LDL
- Increase in HDL
- Decrease in triglycerides
- Decrease in high sensitivity CRP
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||May 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305201
|Pontificia Universidad Catolica de Chile, School of Medicine|
|Principal Investigator:||Arturo Borzutzky, MD||Pontificia Universidad Catolica de Chile, School of Medicine, Department of Pediatrics|
|Study Director:||Miguel Gutierrez, MD||Pontificia Universidad Catolica de Chile, School of Medicine, Department of Rheumatology and Clinical Immunology|