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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04316923
• Other study ID #: WUM CM
• Status: Active, not recruiting
• Start date: March 1, 2020
• Est. completion date: March 2024

Study information

• Verified date: August 2022
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cardiomyopathies

Intervention

Diagnostic Test:
• ECG
ECG will be performed during each visit in the study group.
• 24-hour ECG monitoring
24-hour ECG monitoring will be performed during each visit in the study group.
• Cardio-pulmonary exercise test (CPET)
CPET will be performed during the first and the last visit in the study group.
• Cardiac biomarkers
Cardiac biomarkers will be assessed during each visit in the study group.

Locations

Country	Name	City	State
Poland	Medical Univeristy of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Katarzyna Luczak-Wozniak

Country where clinical trial is conducted

Poland, 

Outcome

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