NCT06348732

Brief Summary

This study aims to assess the the role of cardiac biomarkers (troponin and ProBNP) in pediatric Patients with all types of cardiomyopathy in correlation with echocardiography findings .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

March 4, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

April 5, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 4, 2024

Last Update Submit

March 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic and Prognostic Role of Troponin and Pro BNP in Pediatric Patients with Cardiomyopathy in correlation to Echocardiography findings .

    Assess the relation between the outcome of pediatric patients with cardiomyopathy and the serum levels of Troponin and proBNP with echocardiography findings by follow up serum troponin and pro-BNP at months 1, 3, 6 , 9 ,12 in correlation to echocardiography findings and tissue doppler imaging in the assessment of myocardial systolic and diastolic function , All the tissue doppler echocardiographic imaging with systolic and diastolic myocardial velocities will be acquired at the mitral annuli on apical 4-chamber view , in the mitral inflow Doppler velocities examination , peak early diastolic velocity (E) and peak late diastolic velocity (A) will be measured. In themitral annular TDI velocities examination , peak systolic myocardial velocities (S') , peak early diastolic myocardial velocity (E') and peak late diastolic myocardial velocity (A') will be recorded .

    one year

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients more than one month old and younger than 18 years old with any types of cardiomyopathy treated at Assiut University Children Hospital.

You may qualify if:

  • Patients more than one month old and younger than 18 years old with any types of cardiomyopathy admitted at Assiut University Children Hospital.

You may not qualify if:

  • Patients aged more than 18 years old.
  • Patients aged less than one month old .
  • Patients with congenital heart diseases .
  • Patients with other chronic diseases as : ( chronic kidney diseases , chronic lung diseases, chronic blood diseases and immune deficiency )
  • Patients with acute myocarditis secondary to viral infection .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Hamada T, Kubo T, Kitaoka H, Hirota T, Hoshikawa E, Hayato K, Shimizu Y, Okawa M, Yamasaki N, Matsumura Y, Yabe T, Takata J, Doi YL. Clinical features of the dilated phase of hypertrophic cardiomyopathy in comparison with those of dilated cardiomyopathy. Clin Cardiol. 2010 Jul;33(7):E24-8. doi: 10.1002/clc.20533.

    PMID: 20641106BACKGROUND
  • Ikeda H, Imaizumi T. [Prognosis of hypertrophic and dilated cardiomyopathy]. Nihon Rinsho. 2000 Jan;58(1):86-92. Japanese.

    PMID: 10885294BACKGROUND

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

mahmoud ramadan badawy Hussein, MASTER

CONTACT

HEKMA SAAD FARGHALY, DOCTORATE

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 4, 2024

First Posted

April 5, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

November 1, 2025

Last Updated

April 5, 2024

Record last verified: 2024-03