Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

Sponsor

Pontificia Universidad Catolica de Chile (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00305201

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kawasaki Disease	Drug: pravastatin	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2006

Anticipated Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Percent of change in brachial artery dilatation after statin therapy []

Secondary Outcome Measures

Decrease in LDL []
Increase in HDL []
Decrease in triglycerides []
Decrease in high sensitivity CRP []

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pontificia Universidad Catolica de Chile, School of Medicine	Santiago	Región Metropolitana	Chile

Sponsors and Collaborators

Pontificia Universidad Catolica de Chile
Bristol-Myers Squibb

Investigators

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