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...
Date First Received: March 20, 2006
Last Updated: March 11, 2008
Verified by: Pontificia Universidad Catolica de Chile, March 2008
Clinical Trial Phase: Phase 2 | Start Date: April 2006
Overall Status: Withdrawn
Estimated Enrollment: 22
Brief Summary
Official Title: “Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: pravastatin
Outcome Measures for this Clinical Trial
Primary Measures
- Percent of change in brachial artery dilatation after statin therapy
Secondary Measures
- Decrease in LDL
- Increase in HDL
- Decrease in triglycerides
- Decrease in high sensitivity CRP
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 8 Years
Maximum Age for this Clinical Trial: 25 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pontificia Universidad Catolica de Chile
Overall Clinical Trial Officials and Contacts
Arturo Borzutzky, MD Principal Investigator Pontificia Universidad Catolica de Chile, School of Medicine, Department of Pediatrics
Related Publications
References
Kato H, Sugimura T, Akagi T, Sato N, Hashino K, Maeno Y, Kazue T, Eto G, Yamakawa R. Long-term consequences of Kawasaki disease. A 10- to 21-year follow-up study of 594 patients. Circulation. 1996 Sep 15;94(6):1379-85.
Dhillon R, Clarkson P, Donald AE, Powe AJ, Nash M, Novelli V, Dillon MJ, Deanfield JE. Endothelial dysfunction late after Kawasaki disease. Circulation. 1996 Nov 1;94(9):2103-6.
Furuyama H, Odagawa Y, Katoh C, Iwado Y, Ito Y, Noriyasu K, Mabuchi M, Yoshinaga K, Kuge Y, Kobayashi K, Tamaki N. Altered myocardial flow reserve and endothelial function late after Kawasaki disease. J Pediatr. 2003 Feb;142(2):149-54.
de Jongh S, Lilien MR, op't Roodt J, Stroes ES, Bakker HD, Kastelein JJ. Early statin therapy restores endothelial function in children with familial hypercholesterolemia. J Am Coll Cardiol. 2002 Dec 18;40(12):2117-21.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00305201
Study ID Number: PG-29/05
ClinicalTrials.gov Identifier: NCT00305201
Health Authority: Chile: Instituto de Salud Publica de Chile
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