Status:
COMPLETED
Genotype-Phenotype Associations in Pediatric Cardiomyopathy (PCM GENES)
Lead Sponsor:
Wayne State University
Collaborating Sponsors:
Carelon Research
Children's Hospital Medical Center, Cincinnati
Conditions:
Dilated Cardiomyopathy
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
Brief Summary
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 b...
Detailed Description
Pediatric cardiomyopathy is a heterogeneous genetic disease with high morbidity and mortality in which children often present with fulminant disease leading to death or transplant. The long-term goal ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
544 Patients enrolled
Trial Details
Trial ID
NCT01873963
Start Date
April 1 2013
End Date
March 31 2018
Last Update
May 1 2018
Active Locations (12)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
University of Miami, Jackson Memorial Hospital
Miami, Florida, United States, 33136
3
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
4
Children's Hospital Boston
Boston, Massachusetts, United States, 02115