Cardiomyopathies
Conditions
Brief summary
The aim of the study is to analyze cardiac biomarkers, electrocardiograms and cardio-pulmonary exercise test (CPET) results in children with cardiomyopathies.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTECG
ECG will be performed during each visit in the study group.
DIAGNOSTIC_TEST24-hour ECG monitoring
24-hour ECG monitoring will be performed during each visit in the study group.
DIAGNOSTIC_TESTCardio-pulmonary exercise test (CPET)
CPET will be performed during the first and the last visit in the study group.
DIAGNOSTIC_TESTCardiac biomarkers
Cardiac biomarkers will be assessed during each visit in the study group.
Sponsors
Katarzyna Łuczak-Woźniak
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of ECG (electrocardiographic) differences in children with cardiomyopathies and healthy children. | 14 months | 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. |
| Assessment of differences in CPET results in children with cardiomyopathies and healthy children. | 14 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of progression of heart failure in children with cardiomyopathies | 20 months | Assessment of serum cardiac biomarkers (Troponin I, NT-proBNP) in children with cardiomyopathies during each visit. |
| Assessment of arrhythmia in time in children with cardiomyopathies | 20 months | 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. |
| Assessment of changes in CPET results in children with cardiomyopathies | 20 months | 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. |
Countries
Poland
Outcome results
None listed