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Enrolling by invitation NCT06641830

A Integrated Study in Pediatric Patients with Cardiomyopathy

— Observational Pediatric Cardiomyopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pediatric Cardiomyopathy. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pediatric Cardiomyopathy Cohort Study: the Emerging Role of CMR in Clinical Practice

Overview

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.

Primary outcome measures

  • Major adverse cardiovascular events [Time frame: 10 years after the onset]

Eligibility criteria

Inclusion criteria

  • Pediatric patients diagnosed with cardiomyopathy.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • West China Second University Hospital — Chengdu

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 PMID 33500567
  • Bogle 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 PMID 37288568
  • Arbelo 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 car PMID 37622657
  • Lipshultz 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. PMID 31132865
  • Lee 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. PMID 28912187

Identifiers

NCT: NCT06641830 · WestChinaSUH2024222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗