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

NCT ID: NCT06637748

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-10-31

Brief 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

Conditions

Bronchial Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Echocardiography

Intervention Type: PROCEDURE

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)

Electrocardiography

Intervention Type: PROCEDURE

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

Stable Asthma Group

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

Group Type: ACTIVE_COMPARATOR

Echocardiography

Intervention Type: PROCEDURE

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)

Electrocardiography

Intervention Type: PROCEDURE

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

Interventions

Echocardiography

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)

Intervention Type: PROCEDURE

Electrocardiography

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• . 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Safa Atef Abodaif

Resident-pediatric department-sohag hospital university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university Hospital

Sohag, , Egypt

Countries

Egypt

Central Contacts

Safaa A Abodaif, resident

Role: CONTACT

safaa.atef@med.sohag.edu.eg

01027315284

Eman M Fahmy, assistant professor

Role: CONTACT

References

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.

Reference Type: BACKGROUND

PMID: 25316209 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27498367 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26523405 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33042919 (View on PubMed)

Other Identifiers

soh-Med-24 - 09- 04MS

Identifier Type: -

Identifier Source: org_study_id