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Not yet recruitingNCT06637748Updated Oct 15, 2024

Echo and Electrocardiographic Findings in Children With Bronchial Asthma At Sohag University Hospital

An interventional study of Echocardiography and Electrocardiography in Bronchial Asthma, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Sohag University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
5 Years to 18 Years
Sex
All
01

Study summary

Bronchial asthma is a common respiratory disorder among children, worldwide. Asthma is characterized by chronic inflammation and remodeling of the airways induced by recurrent exposure to hypoxemia that leads to repeated tissue injury and repair. The interaction between respiratory diseases and cardiovascular function is complex . Cardiac dysfunction can be attributed to pulmonary hypertension (PH) secondary to recurrent hypoxia in patients with bronchial asthma. PH affects the pulmonary vasculature by releasing various cytokines leading to pulmonary vasoconstriction and enhancing the remodeling process with muscularization and proliferation of the vascular media and intima . Other hypotheses concluded that the exaggerated respiratory efforts may raise the intrathoracic pressure and increase right ventricle (RV) afterload and consequently RV hypertrophy and/or dilatation . Children with severe bronchial asthma can experience cor pulmonale later in life, but little is known about the early cardiac changes that might be present during childhood especially for mild or moderate persistent asthma. Some studies have reported right ventricular dysfunction as the earliest hemodynamic change among those cases . Other studies did not report these results and reported impaired systolic function of the left ventricle (LV) even before diastolic dysfunction . Insufficient control of BA, in turn, can cause the formation of various pathological conditions. For example, there are studies showing the risk of cardiac arrhythmias and conduction disorders in patients with uncontrolled BA due to functional changes or pathological remodeling of the myocardium . Atrial remodeling, which is the pathomorphological basis of serious supraventricular cardiac arrhythmias, has a more rapid progression with poor BA control and is formed as a result of excessive stretching of the atrial wall, as well as other adverse factors . The connection between BA and supraventricular arrhythmias, including atrial fibrillation (AF), was noted in studies by Cepelis et al. Available data indicate that in the adult population, cardiac arrhythmias are significantly more common in patients with BA than in those without it (9). The results of a Norwegian population study HUNT study, demonstrate that the risks of supraventricular arrhythmias and AF are increased in patients with an uncontrolled BA . Electrocardiography (ECG) is the universal screening method for assessing the state of the atrial myocardium and the conducting system of the heart. According to German et al. ECG analysis can make a significant input to the assessment of the risk of formation of supraventricular rhythm and conduction disorders. Therefore, the analysis of the atrial component of the ECG, and atrioventricular conduction in patients with BA is an important component of the management of these patients, especially in pediatric practice. Consequently, the study of the characteristics of the ECG and its supraventricular component in children with BA is relevan

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Conditions studied

  • Bronchial Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 30 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

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Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Age range: 5-18 years 2. Confirmed diagnosis of bronchial asthma, made in accordance with current international and national consensus documents

Exclusion criteria

Exclusion Criteria:

  • . Known congenital heart disease 2. Presence of acute infectious diseases and fever 3. Diabetes 4. Autoimmune disorders 5. Primary immunodeficiency 6. Cancer 7. Current use of oral glucocorticoids 8. Other chronic respiratory conditions 9. Systemic diseases affecting the cardiovascular system
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Acute Exacerbation Group

    an acute attack, at least 1 month after attack. a. Mild acute exacerbation b. Moderate acute exacerbation c. Severe acute exacerbation, according GINA 2024.

    Procedure: Echocardiography · Procedure: Electrocardiography

  • Active comparator
    Stable Asthma Group

    Patients attending routine follow-up visits with well-controlled asthma

    Procedure: Echocardiography · Procedure: Electrocardiography

Interventions

  • ProcedureEchocardiography

    Transthoracic echocardiography • Parameters assessed: * Right ventricular dimensions and function * Pulmonary artery pressure estimation * Valvular function assessment * Left ventricular dimensions (end-diastolic and end-systolic)o Left ventricular function (ejection fraction, fractional shortening)

  • ProcedureElectrocardiography

    Standard 12-lead ECG recording • Parameters assessed: * Heart rate and rhythm * P-wave morphology * PR interval * QRS complex duration and morphology * ST-segment changes * T-wave abnormalities * QT interval

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What researchers measure

Primary outcomes

  1. Changes in ECG parameters from baseline to follow-up

    Standard 12-lead ECG recording • Parameters assessed: * Heart rate and rhythm * P-wave morphology * PR interval * QRS complex duration and morphology * ST-segment changes * T-wave abnormalities * QT interval

    Time frame: 1 year

Secondary outcomes

  1. Changes in echocardiographic parameters from baseline to follow-up

    Transthoracic echocardiography • Parameters assessed: * Right ventricular dimensions and function * Pulmonary artery pressure estimation * Valvular function assessment * Left ventricular dimensions (end-diastolic and end-systolic) * Left ventricular function (ejection fraction, fractional shortening)

    Time frame: 1year

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Study locations

1 site
  • Sohag university Hospital
    Sohag, Sohag, Egypt
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References and documents

Publications

  • Harkness LM, Kanabar V, Sharma HS, Westergren-Thorsson G, Larsson-Callerfelt AK. Pulmonary vascular changes in asthma and COPD. Pulm Pharmacol Ther. 2014 Dec;29(2):144-55. doi: 10.1016/j.pupt.2014.09.003. Epub 2014 Oct 12. PubMed 25316209 ↗
  • Wang X, Liu C, Wu L, Zhu S. Potent ameliorating effect of Hypoxia-inducible factor 1alpha (HIF-1alpha) antagonist YC-1 on combined allergic rhinitis and asthma syndrome (CARAS) in Rats. Eur J Pharmacol. 2016 Oct 5;788:343-350. doi: 10.1016/j.ejphar.2016.07.040. Epub 2016 Aug 4. PubMed 27498367 ↗
  • German DM, Kabir MM, Dewland TA, Henrikson CA, Tereshchenko LG. Atrial Fibrillation Predictors: Importance of the Electrocardiogram. Ann Noninvasive Electrocardiol. 2016 Jan;21(1):20-9. doi: 10.1111/anec.12321. Epub 2015 Nov 2. PubMed 26523405 ↗
  • Gordina AV, Egoshina KA, Eliseeva TI, Vinogradova NG, Ovsyannikov DY, Tush EV, Prakhov AV, Daniel-Abu MI, Khaletskaya OV, Kubysheva NI. The Relationship Between Bronchial Patency and Parameters of ECG Supraventricular Component in Children With Bronchial Asthma. Front Pediatr. 2020 Sep 16;8:576. doi: 10.3389/fped.2020.00576. eCollection 2020. PubMed 33042919 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06637748
Lead sponsor
Sohag University
Responsible party
Safa Atef Abodaif (Resident-pediatric department-sohag hospital university, Sohag University) — Principal investigator
First posted
Oct 15, 2024
Start date
Oct 2024 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Oct 15, 2024

Study contacts

Safaa A Abodaif, resident
Contact
safaa.atef@med.sohag.edu.eg
01027315284
Eman M Fahmy, assistant professor
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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