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Not yet recruitingNCT05985720Updated Aug 14, 2023

Evaluation of Cardiac Biomarkers and Ventricular Function in Asthmatic Children

An observational study in Ventricular Dysfunction and Asthma in Children, sponsored by Assiut University. Not yet recruiting. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 7 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
50
Ages
5 Years to 15 Years
Sex
All
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Study summary

Evaluation of cardiac biomarkers and the left and right ventricular systolic and diastolic function in asthmatic children in Assuit university hospital

Read the detailed description

Severe acute asthma which is defined asthma that is uncontrolled despite maximal optimized therapy and treatment of contributory factors, or that worsens when high dose treatment is decreased(1) and it is characterized by severe respiratory distress because of increasing bronchoconstriction, leading to ventilation perfusion mismatch, hypoxia, respiratory muscle fatigue, carbon dioxide retention and respiratory acidosis(2) In acute severe asthma, the use of beta 2 agonists, together with hypoxia and tachycardia might cause increased myocardial workload further leading to myocardial infarction(3).

Cardiac biomarkers including Brain Natriuretic Peptide (BNP),Troponin I (TnI) and Creatine kinase muscle/brain(CK-MB) are used to detect myocardial injury(4).

The objective of the present study was to find out the incidence of myocardial dysfunction in patients of acute severe bronchial asthma based on cardiac biomarker levels at admission and to see whether the myocardial dysfunction was transient or persistent even after the stabilization of the patient. As far as it could be reviewed, no study relating BNP levels in pediatric asthma patients could be found in literature.

Echocardiographic changes in bronchial asthma regarding RT ventricular and Ltventricular function will be assessed According to some studies right ventricular (RV) systolic and diastolic dysfunction were detected, even in mild cases, by echocardiography. On the other hand, left ventricular (LV) dysfunction usually presents itself in severe asthmatic cases which may be reversible in acute conditions (5).

Some studies showed that there were no differences in echocardiographic findings regarding the ventricular function with the exception of RV wall thickness (6).

Asthma affects ventricular contractility in children. Although cardiac systolic function was found to be impaired in asthmatic patients, contrary to the literature diastolic dysfunction didn't observed in these patients even by tissue Doppler imaging, may be due to using inhaled corticosteroid(7). This was one of the most comprehensive studies among asthmatic patients. Further studies with larger sample sizes or without using corticosteroid treatment war ranted to better elucidate the cardiac function.

02

Conditions studied

  • Ventricular Dysfunction
  • Asthma in Children

Keywords

  • asthma
  • cardiac affection
03

In context

Ventricular Dysfunction

85 studies on the registry are indexed under Ventricular Dysfunction; 11 are open to participants now.

This study's planned enrollment of 50 is below the median of 140 across 34 observational studies indexed under Ventricular Dysfunction.

Browse Ventricular Dysfunction studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

children aged from 5 years to 15 years diagnosed as bronchial asthma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all pediatric cases between the age of 5 -15years with acute severe bronchial asthma who were admitted in pediatric emergency care unit

Exclusion criteria

Exclusion Criteria:

  • Children with congenital or acquired heart diseases
  • Foreign body aspiration .
  • Chest infections
  • Tuberculosis or pneumonia
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. to identify the relation between asthmatic children and cardiac function

    relation between asthma and cardiac function

    Time frame: Baseline

  2. to identify the relation between asthmatic children and myocardial dysfunction

    relation between asthma and myocardial dysfunction

    Time frame: Baseline

Other outcomes

  1. to identify the relation between asthmatic children and child weight

    relation between asthma outcome and patient wieght

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Rodriguez-Roisin R, Ballester E, Roca J, Torres A, Wagner PD. Mechanisms of hypoxemia in patients with status asthmaticus requiring mechanical ventilation. Am Rev Respir Dis. 1989 Mar;139(3):732-9. doi: 10.1164/ajrccm/139.3.732. PubMed 2923373 ↗
  • Peng SM, Sun P, Zeng J, Deng XM. [Cardiac function of children with bronchial asthma]. Zhongguo Dang Dai Er Ke Za Zhi. 2006 Oct;8(5):388-90. Chinese. PubMed 17052399 ↗
  • Zeybek C, Yalcin Y, Erdem A, Polat TB, Aktuglu-Zeybek AC, Bayoglu V, Akdeniz C, Celebi A. Tissue Doppler echocardiographic assessment of cardiac function in children with bronchial asthma. Pediatr Int. 2007 Dec;49(6):911-7. doi: 10.1111/j.1442-200X.2007.02486.x. PubMed 18045296 ↗
  • Shedeed SA. Right ventricular function in children with bronchial asthma: a tissue Doppler echocardiographic study. Pediatr Cardiol. 2010 Oct;31(7):1008-15. doi: 10.1007/s00246-010-9753-2. Epub 2010 Aug 10. PubMed 20697704 ↗
  • Sears MR. Trends in the prevalence of asthma. Chest. 2014 Feb;145(2):219-225. doi: 10.1378/chest.13-2059. PubMed 24493506 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2023; primary completion for Apr 2024, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2023
First posted
Aug 14, 2023
StartEst.
Dec 2023
Primary completionEst.
Apr 2024
CompletionEst.
Apr 2024
Last update
Aug 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05985720
Lead sponsor
Assiut University
Responsible party
Asmaa Khalaf Saber (Principal Investigator, Assiut University) — Principal investigator
First posted
Aug 14, 2023
Start date
Dec 2023 (estimated)
Primary completion
Apr 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Aug 14, 2023

Oversight

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 Jul 2023. You cannot join it, but the record below documents what was studied.

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