Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

Phase 2

Withdrawn

• Conditions: Kawasaki Disease

• Registration Number: NCT00305201
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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 Description

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.

Study Timeline

• Study First Submitted: 2006-03-20
• Study First Submitted QC: 2006-03-20
• Study First Posted: 2006-03-21
• Study Start: 2006-04
• Study Completion: 2007-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-22
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• History of Kawasaki disease more than 12 months before enrollment
• Present age of 8 years or older

Exclusion Criteria

• Diabetes mellitus
• Not controlled hypertension
• Treatment with drugs thay modify endothelial function such as angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, and calcium channel blockers
• Smokers of more than 5 cigarettes per day
• Total cholesterol higher than 250 mg/dl
• Triglycerides higher than 300mg/dl
• Chronic treatment with statins
• Chronic renal insufficiency (creatinine > 1.5 mg/dl)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent of change in brachial artery dilatation after statin therapy

Secondary Outcome Measures

Name	Time	Method
Decrease in LDL
Increase in HDL
Decrease in triglycerides
Decrease in high sensitivity CRP

Trial Locations

Locations (1)

Pontificia Universidad Catolica de Chile, School of Medicine; 🇨🇱 Santiago, Región Metropolitana, Chile