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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment of ECG (electrocardiographic) differences in children with cardiomyopathies and healthy children.
研究概览
简要总结
The aim of the study is to analyze cardiac biomarkers, electrocardiograms and cardio-pulmonary exercise test (CPET) results in children with cardiomyopathies.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Assessment of ECG (electrocardiographic) differences in children with cardiomyopathies and healthy children.
时间窗: 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.
时间窗: 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).
次要结局
- Assessment of progression of heart failure in children with cardiomyopathies(20 months)
- Assessment of arrhythmia in time in children with cardiomyopathies(20 months)
- Assessment of changes in CPET results in children with cardiomyopathies(20 months)
研究者
Katarzyna Łuczak-Woźniak
MD, Department of Pediatric Cardiology and General Pediatrics, Medical University of Warsaw, Warsaw, Poland.
Medical University of Warsaw