Cardiomyopathies Clinical Trial
Official title:
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
Verified date | August 2022 |
Source | Medical University of Warsaw |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The aim of the study is to analyze cardiac biomarkers, electrocardiograms and cardio-pulmonary exercise test (CPET) results in children with cardiomyopathies.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | March 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Day to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Poland | Medical Univeristy of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Katarzyna Luczak-Wozniak |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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