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Cardiac Biomarkers in Pediatric Cardiomyopathy: Study Design and Recruitment Results from the Pediatric
Melanie D Everitt1, James D Wilkinson2, Ling Shi3
1University of Colorado and Children's Hospital Colorado, Denver, CO.
Insights
Pediatric cardiomyopathies are serious heart conditions. This study investigates serum biomarkers to predict outcomes in children with dilated cardiomyopathy (DCM) and hypertrophic cardiomyopathy (HCM), aiming to improve prognosis and management.
Area of Science:
- Pediatric Cardiology
- Biomarker Discovery
- Cardiovascular Research
Background:
- Cardiomyopathies are a significant cause of pediatric heart failure, sudden death, and transplant needs.
- Nearly 40% of children with symptomatic cardiomyopathy face mortality or transplant within two years.
- Circulating biomarkers for predicting outcomes in pediatric cardiomyopathy remain largely uncharacterized.
Purpose of the Study:
- To identify serum biomarkers for predicting outcomes in pediatric patients with dilated cardiomyopathy (DCM) and hypertrophic cardiomyopathy (HCM).
- To enhance the prognosis and management strategies for children diagnosed with these cardiomyopathies.
Main Methods:
- A multi-center prospective study (PCM Biomarkers) involving the Pediatric Cardiomyopathy Registry (PCMR).
- Enrollment of patients under 21 years with DCM or HCM, categorized into new onset or chronic cohorts.
- Tracking of clinical endpoints including sudden death and progressive heart failure.
Main Results:
- 288 children were enrolled, with a mean age at diagnosis of 7.2 years.
- The study included cohorts for new onset DCM (80 children) and chronic DCM/HCM (141 children).
- Data collection focused on time from diagnosis to enrollment for outcome prediction.
Conclusions:
- The PCM Biomarkers study is crucial for evaluating the predictive utility of serum biomarkers in pediatric DCM and HCM.
- Findings will offer vital insights into managing and predicting outcomes where current data is limited.
Background:
Cardiomyopathies are a rare cause of pediatric heart disease, but they are one of the leading causes of heart failure admissions, sudden death, and need for heart transplant in childhood. Reports from the Pediatric Cardiomyopathy Registry (PCMR) have shown that almost 40% of children presenting with symptomatic cardiomyopathy either die or undergo heart transplant within 2 years of presentation. Little is known regarding circulating biomarkers as predictors of outcome in pediatric cardiomyopathy.
Study Design:
The Cardiac Biomarkers in Pediatric Cardiomyopathy (PCM Biomarkers) study is a multi-center prospective study conducted by the PCMR investigators to identify serum biomarkers for predicting outcome in children with dilated cardiomyopathy (DCM) and hypertrophic cardiomyopathy (HCM). Patients less than 21 years of age with either DCM or HCM were eligible. Those with DCM were enrolled into cohorts based on time from cardiomyopathy diagnosis: categorized as new onset or chronic. Clinical endpoints included sudden death and progressive heart failure.
Results:
There were 288 children diagnosed at a mean age of 7.2±6.3 years who enrolled in the PCM Biomarkers Study at a median time from diagnosis to enrollment of 1.9 years. There were 80 children enrolled in the new onset DCM cohort, defined as diagnosis at or 12 months prior to enrollment. The median age at diagnosis for the new onset DCM was 1.7 years and median time from diagnosis to enrollment was 0.1 years. There were 141 children enrolled with either chronic DCM or chronic HCM, defined as children ≥2 years from diagnosis to enrollment. Among children with chronic cardiomyopathy, median age at diagnosis was 3.4 years and median time from diagnosis to enrollment was 4.8 years.
Conclusion:
The PCM Biomarkers study is evaluating the predictive value of serum biomarkers to aid in the prognosis and management of children with DCM and HCM. The results will provide valuable information where data are lacking in children.
Clinical Trial Registration Nct01873976:
https://clinicaltrials.gov/ct2/show/NCT01873976?term=PCM+Biomarker&rank=1.
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