Clinical Trial: Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Pontificia Universidad Catolica de Chile

Current Primary Outcome: Percent of change in brachial artery dilatation after statin therapy

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Decrease in LDL
  • Increase in HDL
  • Decrease in triglycerides
  • Decrease in high sensitivity CRP


Original Secondary Outcome: Same as current

Information By: Pontificia Universidad Catolica de Chile

Dates:
Date Received: March 20, 2006
Date Started: April 2006
Date Completion: May 2007
Last Updated: May 22, 2016
Last Verified: May 2016