Analysis of Cardiac Biomarkers, ECG and CPET Results in Children With Cardiomyopathies

Study Overview
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Brief Summary
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The aim of the study is to analyze cardiac biomarkers, electrocardiograms and cardio-pulmonary exercise test (CPET) results in children with cardiomyopathies.

Detailed Description
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The study group will consist of children that have been diagnosed with DCM, HCM or LVNC. The control group will be composed of healthy children. Examination of cardiac biomarkers (in the study group), ECG, 24-hour- ECG monitoring, CPET will be performed. Patients in the study group will be invited for 2 consecutive visits (in 6-10 months intervals). During the first and the last visit CPET will be performed. The control group will not be invited for consecutive visits.

Official Title
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Analysis of Cardiac Biomarkers, Electrocardiograms and Cardio-pulmonary Exercise Test (CPET) Results in Children With Dilated (DCM), Hypertrophic (HCM) and Left-ventricle Non-compaction (LVNC) Cardiomyopathies

Conditions
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Cardiomyopathies

Intervention / Treatment
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* Diagnostic Test: ECG
* Diagnostic Test: 24-hour ECG monitoring
* Diagnostic Test: Cardio-pulmonary exercise test (CPET)
* Diagnostic Test: Cardiac biomarkers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with HCM, DCM, LVNC diagnosed in 2D echo. Healthy children with no congenital heart disease (CHD) in 2D echo. Patients who signed consent form. Exclusion Criteria: Patients with coexisting CHD, kidney and liver disfunction, taking anti-psychotic and anti-depressant medication, or patients with bundle bunch blocks in ECG. no consent form signed.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with cardiomyopathies<br>Children aged 0-18 years that have been diagnosed with DCM, HCM or LVNC on the basis of a two-dimensional echocardiography with color Doppler. | Diagnostic Test: ECG<br>* ECG will be performed during each visit in the study group.<br>Diagnostic Test: 24-hour ECG monitoring<br>* 24-hour ECG monitoring will be performed during each visit in the study group.<br>Diagnostic Test: Cardio-pulmonary exercise test (CPET)<br>* CPET will be performed during the first and the last visit in the study group.<br>Diagnostic Test: Cardiac biomarkers<br>* Cardiac biomarkers will be assessed during each visit in the study group.<br>|
| Healthy children<br>The control group will be composed of healthy children, in whom heart disease will be excluded using echocardiography. | Diagnostic Test: ECG<br>* ECG will be performed during each visit in the study group.<br>Diagnostic Test: 24-hour ECG monitoring<br>* 24-hour ECG monitoring will be performed during each visit in the study group.<br>Diagnostic Test: Cardio-pulmonary exercise test (CPET)<br>* CPET will be performed during the first and the last visit in the study group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of ECG (electrocardiographic) differences in children with cardiomyopathies and healthy children. | Assessment of heart rhythm, heart rate (BPM), PQ, QRS, QT, QTc intervals, QRS-T angle and arrythmia in ECG. These will be compared with arrythmia severity in 24-hour ecg monitoring. | 14 months | 
| Assessment of differences in CPET results in children with cardiomyopathies and healthy children. | Assessment of peak respiratory oxygen uptake (peakVo2), carbon dioxide production (Vco2), anaerobic threshold (AT), expired ventilation (VE), ventilatory equivalent for CO2 (VE/VCO2), VO2/Work rate relationship, maximal workload (W), duration of exercise (T). | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of progression of heart failure in children with cardiomyopathies | Assessment of serum cardiac biomarkers (Troponin I, NT-proBNP) in children with cardiomyopathies during each visit. | 20 months | 
| Assessment of arrhythmia in time in children with cardiomyopathies | Assessment of heart rhythm, heart rate (BPM), PQ, QRS, QT, QTc intervals, QRS-T angle and arrythmia in ECG during each control visit. The results will be compared to the severity of arrythmia in 24-hour ecg monitoring. These test will be performed during each visit. | 20 months | 
| Assessment of changes in CPET results in children with cardiomyopathies | Assessment of peak respiratory oxygen uptake (peakVo2), carbon dioxide production (Vco2), anaerobic threshold (AT), expired ventilation (VE), ventilatory equivalent for CO2 (VE/VCO2), VO2/Work rate relationship, maximal workload (W), duration of exercise (T). CPET will be performed in during the first and the last control visit. | 20 months |