NCT04316923

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Katarzyna Łuczak-Woźniak · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiomyopathies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-03-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2020-03-20
• Last updated: 2022-08-18

Locations

1 site across 1 country: Poland