Trial record 2 of 19 for:    "Kawasaki disease"

Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease

This study has been withdrawn prior to enrollment.
(Withdrawn due to lack of study participants)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT00305201
First received: March 20, 2006
Last updated: March 11, 2008
Last verified: March 2008
  Purpose

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
Kawasaki Disease
Drug: pravastatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cardiovascular Risk Markers Before and After Therapy With Statins in Patients With History of Kawasaki Disease

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

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

Estimated Enrollment: 22
Study Start Date: April 2006
Estimated Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   8 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305201

Locations
Chile
Pontificia Universidad Catolica de Chile, School of Medicine
Santiago, 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
  More Information

Publications:
Responsible Party: Arturo Borzutzky, MD, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT00305201     History of Changes
Other Study ID Numbers: PG-29/05
Study First Received: March 20, 2006
Last Updated: March 11, 2008
Health Authority: Chile: Instituto de Salud Pública de Chile

Keywords provided by Pontificia Universidad Catolica de Chile:
Mucocutaneous Lymph Node Syndrome
Kawasaki disease
Endothelial dysfunction
Pravastatin
Statin therapy

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014