Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

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Brief Title

Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

Official Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percent of change in brachial artery dilatation after statin therapy

Secondary Outcome

 Decrease in LDL

Condition

Kawasaki Disease

Intervention

pravastatin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

April 2006

Completion Date

May 2007


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

Ages

8 Years - 25 Years

Accepts Healthy Volunteers

No

Contacts

Arturo Borzutzky, MD, , 

Location Countries

Chile

Location Countries

Chile

Administrative Informations


NCT ID

NCT00305201

Organization ID

PG-29/05



Study Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

 Bristol-Myers Squibb

Study Sponsor

Arturo Borzutzky, MD, Principal Investigator, Pontificia Universidad Catolica de Chile, School of Medicine, Department of Pediatrics


Verification Date

May 2016