NCT00305201

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

First QC Date

March 20, 2006

Last Update Submit

May 22, 2016

Conditions

Kawasaki Disease

Keywords

Mucocutaneous Lymph Node SyndromeKawasaki diseaseEndothelial dysfunctionPravastatinStatin therapy

Outcome Measures

Primary Outcomes (1)

  • Percent of change in brachial artery dilatation after statin therapy

Secondary Outcomes (4)

  • Decrease in LDL

  • Increase in HDL

  • Decrease in triglycerides

  • Decrease in high sensitivity CRP

Interventions

pravastatinDRUG

Eligibility Criteria

Age8 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • History of Kawasaki disease more than 12 months before enrollment
  • Present age of 8 years or older

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Catolica de Chile, School of Medicine

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (4)

  • 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. doi: 10.1161/01.cir.94.6.1379.

    PMID: 8822996BACKGROUND

  • 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. doi: 10.1161/01.cir.94.9.2103.

    PMID: 8901658BACKGROUND

  • 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. doi: 10.1067/mpd.2003.46.

    PMID: 12584536BACKGROUND

  • 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. doi: 10.1016/s0735-1097(02)02593-7.

    PMID: 12505222BACKGROUND

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Arturo Borzutzky, MD

    Pontificia Universidad Catolica de Chile, School of Medicine, Department of Pediatrics

    PRINCIPAL INVESTIGATOR

  • Miguel Gutierrez, MD

    Pontificia Universidad Catolica de Chile, School of Medicine, Department of Rheumatology and Clinical Immunology

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 21, 2006

Study Start

April 1, 2006

Study Completion

May 1, 2007

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations

CL(1)