Cardiac Biomarkers in Pediatric Cardiomyopathy (PCM Biomarkers)

Status unconfirmed

Conditions studied: Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy

In brief

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. Natural substances in the blood called cardiac biomarkers can be measured in the laboratory and could be a less invasive way (compared to echocardiograms or MRIs) to detect heart dysfunction in children with cardiomyopathy. Little is known about how useful and valid cardiac biomarkers are in the diagnosis and determination of the symptoms in children with cardiomyopathy. The long-term goal of this project is to study how helpful measuring cardiac biomarkers in children with cardiomyopathy is to their doctors in managing the care of these patients as well as improving their overall health. Measures of these cardiac biomarkers could help doctors in determining how best to care for a child with cardiomyopathy, including when to consider heart transplantation as a treatment option.

Key facts

Study ID: NCT01873976
Run by: Wayne State University
People needed: 288
Starts: 2013-06-01
Expected to finish: 2022-06-01
Last updated by the study team: 2020-10-19

Who can join

Age: any, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

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:
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

Where it is running

Children's Hospital Colorado — Aurora, Colorado, United States
Ann and Robert H. Lurie Children's Hospital — 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
Children's Hospital of Pittsburgh of UMPC — Pittsburgh, Pennsylvania, United States
Le Bonheur Children's Hospital — Memphis, Tennessee, 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, University of Alberta — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.