Status:
UNKNOWN
Cardiac Biomarkers in Pediatric Cardiomyopathy (PCM Biomarkers)
Lead Sponsor:
Wayne State University
Collaborating Sponsors:
Carelon Research
Washington University School of Medicine
Conditions:
Dilated Cardiomyopathy
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
Up to 20 years
Brief Summary
Cardiomyopathy is a disease of the heart muscle. It is rare, but it can be serious. Cardiomyopathy in children can result in death, disability, heart transplantation or serious heart rhythm disorders....
Detailed Description
Pediatric cardiomyopathy is a heterogeneous disease with high morbidity and mortality in which children often present with fulminant disease leading to death or transplant. Highly sensitive and specif...
Eligibility Criteria
Inclusion
- Patient is alive and has not received a transplant prior to enrollment in the study.
- Under age 21 years at age of enrollment
- For Group 1 (incident DCM), a case of DCM presenting to a study site within 2 years of the original cardiomyopathy diagnosis
- Group 2 (incident/recent HCM), a new or existing diagnosis of idiopathic or familial HCM with a cMRI within 12 months of diagnosis
- Group 3 (prevalent HCM or DCM), any child with a diagnosis of DCM or idiopathic, familial, or HCM due to a known disease-causing mutation who has survived transplant-free at least 12 months from the date of original cardiomyopathy diagnosis
- For all 3 groups, diagnosis of cardiomyopathy must be confirmed by Echocardiographic or cMRI criteria
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:
- Any cardiomyopathy diagnosis other than DCM or idiopathic HCM, familial HCM or HCM due to a known disease-causing gene
- 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
- Congenital heart defects unassociated with malformation syndromes (e.g., valvular heart disease or congenital coronary artery malformations)
- 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 (e.g., growth hormone, corticosteroids, cocaine) or other diseases known to cause hypertrophy
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT01873976
Start Date
June 1 2013
End Date
June 1 2022
Last Update
October 19 2020
Active Locations (13)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, United States, 60611
3
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110