Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

Kawasaki Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00305201
• Other study ID #: PG-29/05
• Status: Withdrawn
• Phase: Phase 2
• First received: March 20, 2006
• Last updated: May 22, 2016
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: May 2016
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 25 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

Drug:
• pravastatin

Locations

Country	Name	City	State
Chile	Pontificia Universidad Catolica de Chile, School of Medicine	Santiago	Región Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Bristol-Myers Squibb

Country where clinical trial is conducted

Chile, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of change in brachial artery dilatation after statin therapy
Secondary	Decrease in LDL
Secondary	Increase in HDL
Secondary	Decrease in triglycerides
Secondary	Decrease in high sensitivity CRP