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Sponsors and Collaborators: |
Pontificia Universidad Catolica de Chile Bristol-Myers Squibb |
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Information provided by: | Pontificia Universidad Catolica de Chile |
ClinicalTrials.gov Identifier: | NCT00305201 |
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 | Intervention | Phase |
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Kawasaki Disease |
Drug: pravastatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease |
Estimated Enrollment: | 22 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | May 2007 |
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.
Ages Eligible for Study: | 8 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Chile, - | |
Pontificia Universidad Catolica de Chile, School of Medicine | |
Santiago, -, Chile, - |
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 |
Responsible Party: | Pontificia Universidad Catolica de Chile ( Arturo Borzutzky, MD ) |
Study ID Numbers: | PG-29/05 |
Study First Received: | March 20, 2006 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00305201 |
Health Authority: | Chile: Instituto de Salud Publica de Chile |
Mucocutaneous Lymph Node Syndrome Kawasaki disease Endothelial dysfunction Pravastatin Statin therapy |
Mucocutaneous Lymph Node Syndrome Pravastatin Lymphatic Diseases Vasculitis |
Kawasaki syndrome Skin Diseases Vascular Diseases |
Antimetabolites Skin Diseases, Vascular Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |