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

• Conditions: Cardiomyopathies
• Interventions: Diagnostic Test: ECG; Diagnostic Test: 24-hour ECG monitoring; Diagnostic Test: Cardio-pulmonary exercise test (CPET); Diagnostic Test: Cardiac biomarkers

• Registration Number: NCT04316923
• Lead Sponsor: Katarzyna Łuczak-Woźniak

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-20
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with cardiomyopathies	Cardiac biomarkers	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.
Children with cardiomyopathies	ECG	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.
Healthy children	Cardio-pulmonary exercise test (CPET)	The control group will be composed of healthy children, in whom heart disease will be excluded using echocardiography.
Children with cardiomyopathies	24-hour ECG monitoring	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.
Children with cardiomyopathies	Cardio-pulmonary exercise test (CPET)	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.
Healthy children	ECG	The control group will be composed of healthy children, in whom heart disease will be excluded using echocardiography.
Healthy children	24-hour ECG monitoring	The control group will be composed of healthy children, in whom heart disease will be excluded using echocardiography.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Medical Univeristy of Warsaw; 🇵🇱 Warsaw, Poland