Pediatric CardiomyopathyNCT06641830
A Integrated Study in Pediatric Patients with Cardiomyopathy
An observational study of Pediatric Cardiomyopathy, run by West China Second University Hospital at 1 site in China.
Trial summary
This observational study aims to manage children with cardiomyopathy in the long term. It collects baseline data, laboratory test data, and medical imaging data during the hospitalization and follow-up. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cardiomyopathy
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 30 Sep 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: From the past to Jaunary 2034, pediatric patients diagnosed with cardiomyopathy were recruited from West China Second University Hospital.
Who may be able to join
- Pediatric patients diagnosed with cardiomyopathy.
Who cannot join
- a history of cardiovascular disease ( such as congenital heart disease, cardiomyopathy, rheumatic heart disease, valvular disease ).
- Mentally abnormal.
- Poor compliance.
- Heart, kidney and other important organs were seriously incomplete.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Pediatric Cardiomyopathy Cohort Study: the Emerging Role of CMR in Clinical Practice
This observational study aims to manage children with cardiomyopathy in the long term. It collects baseline data, laboratory test data, and medical imaging data during the hospitalization and follow-up.
During their disease progress, participants will undergo cardiovascular magnetic resonance, echocardiography, electrocardiography, laboratory tests, and when hospitalization and follow-up, and the baseline data will be collected in the admission. All the above examination data will be analysed to assess the clinical characteristics, current status of diagnosis and treatment, and the prognostic risk factors for children with cardiomyopathy.
- Conditions
- Pediatric Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pediatric patients with cardiomyopathy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Major adverse cardiovascular events including cardiac death, transient ischemic attack or stroke, myocardial infarction, arrhythmia, heart failure, severe valvular disease, percutaneous coronary intervention, coronary artery bypass graft, and other cardiovascular surgery.
Measured: 10 years after the onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Jan 2034 (estimated)
- Study completion30 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pediatric CardiomyopathyStudies 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Yi Wen, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641830
- Sponsor's protocol ID
- WestChinaSUH2024222
- Status last verified
- Sep 2024
- First submitted
- 8 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mazzarotto F, Hawley MH, Beltrami M, Beekman L, de Marvao A, McGurk KA, Statton B, Boschi B, Girolami F, Roberts AM, Lodder EM, Allouba M, Romeih S, Aguib Y, Baksi AJ, Pantazis A, Prasad SK, Cerbai E, Yacoub MH, O'Regan DP, Cook SA, Ware JS, Funke B, Olivotto I, Bezzina CR, Barton PJR, Walsh R. Systematic large-scale assessment of the genetic architecture of left ventricular noncompaction reveals diverse etiologies. Genet Med. 2021 May;23(5):856-864. doi: 10.1038/s41436-020-01049-x. Epub 2021 Jan 26.
PubMed 33500567Bogle C, Colan SD, Miyamoto SD, Choudhry S, Baez-Hernandez N, Brickler MM, Feingold B, Lal AK, Lee TM, Canter CE, Lipshultz SE; American Heart Association Young Hearts Pediatric Heart Failure and Transplantation Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young (Young Hearts). Treatment Strategies for Cardiomyopathy in Children: A Scientific Statement From the American Heart Association. Circulation. 2023 Jul 11;148(2):174-195. doi: 10.1161/CIR.0000000000001151. Epub 2023 Jun 8.
PubMed 37288568Arbelo E, Protonotarios A, Gimeno JR, Arbustini E, Barriales-Villa R, Basso C, Bezzina CR, Biagini E, Blom NA, de Boer RA, De Winter T, Elliott PM, Flather M, Garcia-Pavia P, Haugaa KH, Ingles J, Jurcut RO, Klaassen S, Limongelli G, Loeys B, Mogensen J, Olivotto I, Pantazis A, Sharma S, Van Tintelen JP, Ware JS, Kaski JP; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023 Oct 1;44(37):3503-3626. doi: 10.1093/eurheartj/ehad194. No abstract available.
PubMed 37622657Lipshultz SE, Law YM, Asante-Korang A, Austin ED, Dipchand AI, Everitt MD, Hsu DT, Lin KY, Price JF, Wilkinson JD, Colan SD. Cardiomyopathy in Children: Classification and Diagnosis: A Scientific Statement From the American Heart Association. Circulation. 2019 Jul 2;140(1):e9-e68. doi: 10.1161/CIR.0000000000000682. Epub 2019 May 28.
PubMed 31132865Lee TM, Hsu DT, Kantor P, Towbin JA, Ware SM, Colan SD, Chung WK, Jefferies JL, Rossano JW, Castleberry CD, Addonizio LJ, Lal AK, Lamour JM, Miller EM, Thrush PT, Czachor JD, Razoky H, Hill A, Lipshultz SE. Pediatric Cardiomyopathies. Circ Res. 2017 Sep 15;121(7):855-873. doi: 10.1161/CIRCRESAHA.116.309386.
PubMed 28912187
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pediatric Cardiomyopathy Cohort Study: the Emerging Role of CMR in Clinical Practice
- ClinicalTrials.gov ID
- NCT06641830
- Acronym / sponsor ID
- WestChinaSUH2024222
- Conditions
- Pediatric Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jan 2034 (estimated)
- Study completion
- 30 Sep 2034 (estimated)
- First posted
- 15 Oct 2024 (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.
This observational study aims to manage children with cardiomyopathy in the long term. It collects baseline data, laboratory test data, and medical imaging data during the hospitalization and follow-up.
During their disease progress, participants will undergo cardiovascular magnetic resonance, echocardiography, electrocardiography, laboratory tests, and when hospitalization and follow-up, and the baseline data will be collected in the admission. All the above examination data will be analysed to assess the clinical characteristics, current status of diagnosis and treatment, and the prognostic risk factors for children with cardiomyopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patients with cardiomyopathy | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- From the past to Jaunary 2034, pediatric patients diagnosed with cardiomyopathy were recruited from West China Second University Hospital.
Key inclusion criteria (1 listed)
- Pediatric patients diagnosed with cardiomyopathy.
Key exclusion criteria (4 listed)
- a history of cardiovascular disease ( such as congenital heart disease, cardiomyopathy, rheumatic heart disease, valvular disease ).
- Mentally abnormal.
- Poor compliance.
- Heart, kidney and other important organs were seriously incomplete.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiovascular events
Time frame: 10 years after the onset
Major adverse cardiovascular events including cardiac death, transient ischemic attack or stroke, myocardial infarction, arrhythmia, heart failure, severe valvular disease, percutaneous coronary intervention, coronary artery bypass graft, and other cardiovascular surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 33500567Mazzarotto F, Hawley MH, Beltrami M, Beekman L, de Marvao A, McGurk KA, Statton B, Boschi B, Girolami F, Roberts AM, Lodder EM, Allouba M, Romeih S, Aguib Y, Baksi AJ, Pantazis A, Prasad SK, Cerbai E, Yacoub MH, O'Regan DP, Cook SA, Ware JS, Funke B, Olivotto I, Bezzina CR, Barton PJR, Walsh R. Systematic large-scale assessment of the genetic architecture of left ventricular noncompaction reveals diverse etiologies. Genet Med. 2021 May;23(5):856-864. doi: 10.1038/s41436-020-01049-x. Epub 2021 Jan 26.
- Background: PubMed 37288568Bogle C, Colan SD, Miyamoto SD, Choudhry S, Baez-Hernandez N, Brickler MM, Feingold B, Lal AK, Lee TM, Canter CE, Lipshultz SE; American Heart Association Young Hearts Pediatric Heart Failure and Transplantation Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young (Young Hearts). Treatment Strategies for Cardiomyopathy in Children: A Scientific Statement From the American Heart Association. Circulation. 2023 Jul 11;148(2):174-195. doi: 10.1161/CIR.0000000000001151. Epub 2023 Jun 8.
- Background: PubMed 37622657Arbelo E, Protonotarios A, Gimeno JR, Arbustini E, Barriales-Villa R, Basso C, Bezzina CR, Biagini E, Blom NA, de Boer RA, De Winter T, Elliott PM, Flather M, Garcia-Pavia P, Haugaa KH, Ingles J, Jurcut RO, Klaassen S, Limongelli G, Loeys B, Mogensen J, Olivotto I, Pantazis A, Sharma S, Van Tintelen JP, Ware JS, Kaski JP; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023 Oct 1;44(37):3503-3626. doi: 10.1093/eurheartj/ehad194. No abstract available.
- Background: PubMed 31132865Lipshultz SE, Law YM, Asante-Korang A, Austin ED, Dipchand AI, Everitt MD, Hsu DT, Lin KY, Price JF, Wilkinson JD, Colan SD. Cardiomyopathy in Children: Classification and Diagnosis: A Scientific Statement From the American Heart Association. Circulation. 2019 Jul 2;140(1):e9-e68. doi: 10.1161/CIR.0000000000000682. Epub 2019 May 28.
- Background: PubMed 28912187Lee TM, Hsu DT, Kantor P, Towbin JA, Ware SM, Colan SD, Chung WK, Jefferies JL, Rossano JW, Castleberry CD, Addonizio LJ, Lal AK, Lamour JM, Miller EM, Thrush PT, Czachor JD, Razoky H, Hill A, Lipshultz SE. Pediatric Cardiomyopathies. Circ Res. 2017 Sep 15;121(7):855-873. doi: 10.1161/CIRCRESAHA.116.309386.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pediatric Cardiomyopathy, run by West China Second University Hospital at 1 site in China.
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 1 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 15 Oct 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Major adverse cardiovascular events (time frame: 10 years after the onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06641830, which also lists 5 linked publications.
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 15 Oct 2024.