Role of Matrix Metalloproteinases (MMPs) and Tissue Inhibitors of Metalloproteinases (TIMPs) in Children With Myocarditis

This study has been completed.
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00693134
First received: June 4, 2008
Last updated: June 5, 2008
Last verified: February 2008
  Purpose

Children can have or develop certain problems with their heart function, specifically with the heart muscle or myocardium. This problem can be caused by many things specifically by infection resulting in myocarditis (inflammation of the heart muscle) or dilated cardiomyopathy (caused by many factors including high blood pressure and heart attacks). The body goes through many processes to repair the injured tissue including using proteins that cause the muscle mass to increase called matrix metalloproteinases (MMPs). The body also uses proteins that direct the MMPs to stop increasing the muscle mass called tissue inhibitory of metalloproteinases (TIMPs). Currently, there are no published studies that explain or evaluate the relationship that MMPs and TIMPs have in myocarditis and dilated cardiomyopathy in children.

The investigator wishes to perform a prospective study of the serum levels of these proteins and their regulators in children with myocarditis and/or dilated cardiomyopathy and compare them with children that have no heart disease.


Condition
Myocarditis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of Matrix Metalloproteinases and Tissue Inhibitors of Metalloproteinases in Children With Acute Inflammatory Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Determine correlation between proteinases (MMPs and TIMPs) and their regulators in children with acute inflammatory cardiomyopathy. [ Time Frame: Length of hospital stay from time of admission to protocol. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biopsy tissue, if available.


Enrollment: 36
Study Start Date: March 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
Myocarditis Patients
Patients initially diagnosed with myocarditis.
Control Patients
Patients with no known cardiomyopathies

Detailed Description:

All children who present with signs and symptoms of myocarditis and have laboratory findings consistent with cardiomyopathy will be eligible. After prospective consent, all subjects will receive: (1) a complete physical examination, (2) complete transthoracic echocardiogram to better characterize the disease process. Follow-up echocardiograms will be performed at 24-72 hours after admission into the protocol and at discharge from the hospital. Approximately 2 teaspoons of blood will be drawn at: (1) enrollment, (2) 24 hours after, (3) 72 hours after, (4) and at hospital discharge. Those subjects that receive a heart transplant will have blood drawn at the time of transplantation. For those that have a cardiac catheterization or have a muscle biopsy as part of their standard of care, will also have a biopsy of their right ventricle performed.

Data to be collected: Minimum patient demographic data (age, sex, ethnic origin), vital signs, clinical course events/data (i.e. need for dialysis, length of stay, surgical time points, etc), diagnostic test results (EKGs, ECHOs, etc), significant medical history data, and standard of care laboratory results.

The investigator wishes to evaluate the relationship of this data with the patient's diagnosis, clinical course, and serum levels of MMP and TIMP proteinases.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Inpatients of the Cardiac Service at Children's Medical Center.

Criteria

Inclusion Criteria:

1. Evidence from diagnostic tests and physical exam that confirm inflammatory cardiomyopathy.

Exclusion Criteria:

  1. Patients with structural heart disease other than septal defects or patent ductus arteriosus
  2. Patients with history of arrhythmia
  3. Patients with history of ventricular dysfunction diagnosed by echocardiograms
  4. Patients with history of chronic systemic illness
  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: NCT00693134

Locations
United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Tia A Tortoriello-Raymond, MD University of Texas - Southwestern Medical Center, Children's Medical Center
  More Information

No publications provided

Responsible Party: Tia Tortoriello-Raymond, MD, Universtty of Texas - Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00693134     History of Changes
Other Study ID Numbers: 012004-072
Study First Received: June 4, 2008
Last Updated: June 5, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Tissue Inhibitor of Metalloproteinases
Tissue Inhibitor of Metalloproteinase-1
Matrix Metalloproteinase Inhibitors
TIMP1 protein, human
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014