CardiomyopathiesNCT04316923
Analysis of Cardiac Biomarkers, ECG and CPET Results in Children With Cardiomyopathies
An observational study of Cardiomyopathies, run by Katarzyna Łuczak-Woźniak at 1 site in Poland.
Trial summary
The aim of the study is to analyze cardiac biomarkers, electrocardiograms and cardio-pulmonary exercise test (CPET) results in children with cardiomyopathies. Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathies
- What is being tested?
- ECG, 24-hour ECG monitoring and Cardio-pulmonary exercise test (CPET)
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2020to Mar 2024
- How long will I take part?
- 20 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The aim of the study is to analyze cardiac biomarkers, electrocardiograms and cardio-pulmonary exercise test (CPET) results in children with cardiomyopathies.
Read the 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
- Being tested
- ECG, 24-hour ECG monitoring, Cardio-pulmonary exercise test (CPET), Cardiac biomarkers
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDiagnostic test
ECG will be performed during each visit in the study group.
24-hour ECG monitoringDiagnostic test
24-hour ECG monitoring will be performed during each visit in the study group.
Cardio-pulmonary exercise test (CPET)Diagnostic test
CPET will be performed during the first and the last visit in the study group.
Cardiac biomarkersDiagnostic test
Cardiac biomarkers will be assessed during each visit in the study group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ECG; Diagnostic Test: 24-hour ECG monitoring; Diagnostic 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. Receives: Diagnostic Test: ECG; Diagnostic Test: 24-hour ECG monitoring; Diagnostic Test: Cardio-pulmonary exercise test (CPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 14 months
Secondary outcomes (3)
Assessment of progression of heart failure in children with cardiomyopathies
Assessment of serum cardiac biomarkers (Troponin I, NT-proBNP) in children with cardiomyopathies during each visit.
Measured: 20 months
Assessment of arrhythmia in time in children with cardiomyopathies
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.
Measured: 20 months
Assessment of changes in CPET results in children with cardiomyopathies
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.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start1 Mar 2020
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 20 Months
Sponsor and investigators
- Lead sponsor
- Katarzyna Łuczak-Woźniak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katarzyna Łuczak-Woźniak, Medical University of Warsaw
- Investigators
- Katarzyna M Luczak-Wozniak, MD, Principal investigator, Medical Univeristy of Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316923
- Sponsor's protocol ID
- WUM CM
- Status last verified
- Aug 2022
- First submitted
- 5 Mar 2020
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04316923
- Acronym / sponsor ID
- WUM CM
- Conditions
- Cardiomyopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Katarzyna Łuczak-WoźniakUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with cardiomyopathies | – | Diagnostic Test: ECG, Diagnostic Test: 24-hour ECG monitoring, Diagnostic Test: Cardio-pulmonary exercise test (CPET), Diagnostic Test: Cardiac biomarkersChildren aged 0-18 years that have been diagnosed with DCM, HCM or LVNC on the basis of a two-dimensional echocardiography with color Doppler. |
| Healthy children | – | Diagnostic Test: ECG, Diagnostic Test: 24-hour ECG monitoring, Diagnostic Test: Cardio-pulmonary exercise test (CPET)The control group will be composed of healthy children, in whom heart disease will be excluded using echocardiography. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECGECG will be performed during each visit in the study group. | Diagnostic test | Children with cardiomyopathies, Healthy children |
| 24-hour ECG monitoring24-hour ECG monitoring will be performed during each visit in the study group. | Diagnostic test | Children with cardiomyopathies, Healthy children |
| Cardio-pulmonary exercise test (CPET)CPET will be performed during the first and the last visit in the study group. | Diagnostic test | Children with cardiomyopathies, Healthy children |
| Cardiac biomarkersCardiac biomarkers will be assessed during each visit in the study group. | Diagnostic test | Children with cardiomyopathies |
Primary outcome
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).
3 secondary outcomes
Assessment of progression of heart failure in children with cardiomyopathies
Time frame: 20 months
Assessment of arrhythmia in time in children with cardiomyopathies
Time frame: 20 months
Assessment of changes in CPET results in children with cardiomyopathies
Time frame: 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna M Luczak-Wozniak, MD principal investigator
Medical Univeristy of Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies, run by Katarzyna Łuczak-Woźniak at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of ECG (electrocardiographic) differences in children with cardiomyopathies and healthy children. (time frame: 14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.