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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiomyopathies
• Intervention / Treatment: Diagnostic test: ECG; Diagnostic test: 24-hour ECG monitoring; Diagnostic test: Cardio-pulmonary exercise test (CPET); Diagnostic test: Cardiac biomarkers

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • Medical Univeristy of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study group will consist of children aged 0-18 years that have been diagnosed with DCM, HCM or LVNC who are under the care of our Deparment.

The control group will be composed of 30 healthy children, in whom heart disease will be excluded using echocardiography.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with cardiomyopathies; 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.	Diagnostic test: ECG; ECG will be performed during each visit in the study group.; Diagnostic test: 24-hour ECG monitoring; 24-hour ECG monitoring will be performed during each visit in the study group.; Diagnostic test: Cardio-pulmonary exercise test (CPET); CPET will be performed during the first and the last visit in the study group.; Diagnostic test: Cardiac biomarkers; Cardiac biomarkers will be assessed during each visit in the study group.
Healthy children; The control group will be composed of healthy children, in whom heart disease will be excluded using echocardiography.	Diagnostic test: ECG; ECG will be performed during each visit in the study group.; Diagnostic test: 24-hour ECG monitoring; 24-hour ECG monitoring will be performed during each visit in the study group.; Diagnostic test: Cardio-pulmonary exercise test (CPET); CPET will be performed during the first and the last visit in the study group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Katarzyna Łuczak-Woźniak
• Investigators: Principal Investigator: Katarzyna M Luczak-Wozniak, MD, Medical Univeristy of Warsaw, Poland

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2024
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (ACTUAL): March 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: WUM CM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No