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

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ClinicalTrials.gov Identifier: NCT04316923
Recruitment Status : Not yet recruiting
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Katarzyna Łuczak-Woźniak, Medical University of Warsaw

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

Condition or disease Intervention/treatment
Cardiomyopathies 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Months
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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Assessment of progression of heart failure in children with cardiomyopathies [ Time Frame: 20 months ]
    Assessment of serum cardiac biomarkers (Troponin I, NT-proBNP) in children with cardiomyopathies during each visit.

  2. Assessment of arrhythmia in time in children with cardiomyopathies [ Time Frame: 20 months ]
    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.

  3. Assessment of changes in CPET results in children with cardiomyopathies [ Time Frame: 20 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). CPET will be performed in during the first and the last control visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316923


Contacts
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Contact: Katarzyna M Luczak-Wozniak, MD + 48 22 317 9583 katarzyna.luczak-wozniak@wum.edu.pl

Sponsors and Collaborators
Katarzyna Łuczak-Woźniak
Investigators
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Principal Investigator: Katarzyna M Luczak-Wozniak, MD Medical Univeristy of Warsaw, Poland
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Responsible Party: Katarzyna Łuczak-Woźniak, MD, Department of Pediatric Cardiology and General Pediatrics, Medical University of Warsaw, Warsaw, Poland., Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT04316923    
Other Study ID Numbers: WUM CM
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases