Analysis of Cardiac Biomarkers, ECG and CPET Results in Children With Cardiomyopathies
NCT ID: NCT04316923
Last Updated: 2022-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2020-03-01
2024-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Healthy children
The control group will be composed of healthy children, in whom heart disease will be excluded using echocardiography.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Healthy children with no congenital heart disease (CHD) in 2D echo.
* Patients who signed consent form.
Exclusion Criteria
* no consent form signed.
1 Day
18 Years
ALL
Yes
Sponsors
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Katarzyna Łuczak-Woźniak
OTHER
Responsible Party
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Katarzyna Łuczak-Woźniak
MD, Department of Pediatric Cardiology and General Pediatrics, Medical University of Warsaw, Warsaw, Poland.
Principal Investigators
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Katarzyna M Luczak-Wozniak, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Univeristy of Warsaw, Poland
Locations
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Medical Univeristy of Warsaw
Warsaw, , Poland
Countries
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Other Identifiers
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WUM CM
Identifier Type: -
Identifier Source: org_study_id
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