Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

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

Sponsors

Lead Sponsor: Pontificia Universidad Catolica de Chile

Collaborator: Bristol-Myers Squibb

Source 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.

Overall Status Withdrawn
Start Date April 2006
Completion Date May 2007
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent of change in brachial artery dilatation after statin therapy
Secondary Outcome
Measure Time Frame
Decrease in LDL
Increase in HDL
Decrease in triglycerides
Decrease in high sensitivity CRP
Condition
Intervention

Intervention Type: Drug

Intervention Name: pravastatin

Eligibility

Criteria:

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)

Gender: All

Minimum Age: 8 Years

Maximum Age: 25 Years

Healthy Volunteers: No

Overall Official
Location
Facility: Pontificia Universidad Catolica de Chile, School of Medicine
Location Countries

Chile

Verification Date

May 2016

Responsible Party

Name Title: Arturo Borzutzky, MD

Organization: Pontificia Universidad Catolica de Chile

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov