NCT04316923

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

4 years

First QC Date

March 5, 2020

Last Update Submit

August 17, 2022

Conditions

Cardiomyopathies

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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 Arms (2)

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: ECGDiagnostic Test: 24-hour ECG monitoringDiagnostic Test: Cardio-pulmonary exercise test (CPET)Diagnostic Test: Cardiac biomarkers

Healthy children

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

Diagnostic Test: ECGDiagnostic Test: 24-hour ECG monitoringDiagnostic Test: Cardio-pulmonary exercise test (CPET)

Interventions

ECGDIAGNOSTIC_TEST

ECG will be performed during each visit in the study group.

Children with cardiomyopathiesHealthy children
24-hour ECG monitoringDIAGNOSTIC_TEST

24-hour ECG monitoring will be performed during each visit in the study group.

Children with cardiomyopathiesHealthy children
Cardio-pulmonary exercise test (CPET)DIAGNOSTIC_TEST

CPET will be performed during the first and the last visit in the study group.

Children with cardiomyopathiesHealthy children
Cardiac biomarkersDIAGNOSTIC_TEST

Cardiac biomarkers will be assessed during each visit in the study group.

Children with cardiomyopathies

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Univeristy of Warsaw

Warsaw, Poland

Location

MeSH Terms

Conditions

Cardiomyopathies

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Katarzyna M Luczak-Wozniak, MD

    Medical Univeristy of Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Department of Pediatric Cardiology and General Pediatrics, Medical University of Warsaw, Warsaw, Poland.

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 20, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

August 18, 2022

Record last verified: 2022-08

Locations

PL(1)