COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00693134
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 6, 2008
Information provided by:
University of Texas Southwestern Medical Center

Brief Summary:

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 or disease

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 36 participants
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
Study Start Date : March 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Myocarditis Patients
Patients initially diagnosed with myocarditis.
Control Patients
Patients with no known cardiomyopathies

Primary Outcome Measures :
  1. 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. ]

Biospecimen Retention:   Samples Without DNA
Biopsy tissue, if available.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Inpatients of the Cardiac Service at Children's Medical Center.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00693134

Layout table for location information
United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Layout table for investigator information
Principal Investigator: Tia A Tortoriello-Raymond, MD University of Texas - Southwestern Medical Center, Children's Medical Center
Layout table for additonal information
Responsible Party: Tia Tortoriello-Raymond, MD, Universtty of Texas - Southwestern Medical Center Identifier: NCT00693134    
Other Study ID Numbers: 012004-072
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: June 6, 2008
Last Verified: February 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases