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Clinical Trials/NCT04316923
NCT04316923
Unknown
Not Applicable

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

Katarzyna Łuczak-Woźniak1 site in 1 country80 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiomyopathies
Sponsor
Katarzyna Łuczak-Woźniak
Enrollment
80
Locations
1
Primary Endpoint
Assessment of ECG (electrocardiographic) differences in children with cardiomyopathies and healthy children.
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
March 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Katarzyna Łuczak-Woźniak
Responsible Party
Sponsor Investigator
Principal Investigator

Katarzyna Łuczak-Woźniak

MD, Department of Pediatric Cardiology and General Pediatrics, Medical University of Warsaw, Warsaw, Poland.

Medical University of Warsaw

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Assessment of ECG (electrocardiographic) differences in children with cardiomyopathies and healthy children.

Time Frame: 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.

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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