Genotype-Phenotype Associations in Pediatric Cardiomyopathy (PCM GENES)

Completed

Conditions studied: Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Restrictive Cardiomyopathy

In brief

Cardiomyopathy in children is a serious disease which can result in death, disability, heart transplantation or serious heart rhythm disorders. Doctors know little about the causes of cardiomyopathy but would like to learn more. In fact, up to 50-75% of cases in children have no known cause. For this reason, the purpose of this study is to identify genes that cause cardiomyopathy or that influence how people with cardiomyopathy do over time. These findings could improve disease prevention, surveillance, early management, and prognosis.

Key facts

Study ID

NCT01873963

Run by

Wayne State University

People needed

544

Starts

2013-04-01

Expected to finish

2018-03-31

Last updated by the study team

2018-05-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is alive. (except samples from deceased relatives who have consented for testing).Patients who are status-post heart transplant are eligible if pre-transplant longitudinal data are available.
• Under age 18 years at the time of diagnosis of either primary or idiopathic dilated, hypertropic, or restrictive cardiomyopathy.
• A diagnosis of cardiomyopathy which, at the time of diagnosis, was confirmed by echocardiographic criteria or cardiac MRI

You may not qualify if…

• A patient is not eligible for enrollment if one or more of the following conditions are met at the time of presentation with cardiomyopathy:
• Arrhythmogenic right ventricular dysplasia
• Neuromuscular disease (defined by specific conditions)
• Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)
• History of rheumatic fever
• Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)
• HIV infection or born to an HIV positive mother
• Kawasaki disease
• Immunologic disease
• Invasive cardiothoracic procedures or major surgery during the preceding month, except those specifically related to cardiomyopathy including left ventricular assist device (LVAD), extracorporeal membrane oxygenator (ECMO), and automatic implantable cardioverter/defibrillator (AICD) placement.
• Uremia, active or chronic
• Abnormal ventricular size or function that can be attributed to intense physical training or chronic anemia
• Chronic arrhythmia, unless there are studies documenting inclusion criteria prior to the onset of arrhythmia (except a patient with chronic arrhythmia, subsequently ablated, whose cardiomyopathy persists after two months is not to be excluded).
• Malignancy
• Systemic Hypertension
• Pulmonary parenchymal or vascular disease (e.g., cystic fibrosis, cor pulmonale, or pulmonary hypertension)
• Ischemic coronary vascular disease
• Association with drugs known to cause hypertrophy (e.g., growth hormone, corticosteroids, cocaine)
• Genetic syndrome or chromosomal abnormality known to be associated with cardiomyopathy

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• University of Miami, Jackson Memorial Hospital — Miami, Florida, United States
• Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Children's Hospital of New York, Columbia Presbyterian Medical Center — New York, New York, United States
• Children's Hospital at Montefiore — The Bronx, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• Stollery Children's Hospital — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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