Ventricular DysfunctionNCT05985720
Evaluation of Cardiac Biomarkers and Ventricular Function in Asthmatic Children
An observational study of Ventricular Dysfunction and Asthma in Children, run by Assiut University.
Trial summary
Evaluation of cardiac biomarkers and the left and right ventricular systolic and diastolic function in asthmatic children in Assuit university hospital Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Ventricular Dysfunction, Asthma in Children
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: children aged from 5 years to 15 years diagnosed as bronchial asthma
Who may be able to join
- all pediatric cases between the age of 5 -15years with acute severe bronchial asthma who were admitted in pediatric emergency care unit
Who cannot join
- Children with congenital or acquired heart diseases
- Foreign body aspiration .
- Chest infections
- Tuberculosis or pneumonia
About this study
Official title: Evaluation of Cardiac Biomarkers and the Left and Right Ventricular Systolic and Diastolic Function in Asthmatic Children in Assuit University Hospital
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.
- Conditions
- Ventricular Dysfunction, Asthma in Children
- Keywords
- asthma, cardiac affection
- Medical subject headings
- Ventricular Dysfunction, Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
to identify the relation between asthmatic children and cardiac function
relation between asthma and cardiac function
Measured: Baseline
to identify the relation between asthmatic children and myocardial dysfunction
relation between asthma and myocardial dysfunction
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study startDec 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Khalaf Saber, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985720
- Sponsor's protocol ID
- Asthmatic children
- Status last verified
- Jul 2023
- First submitted
- 30 Mar 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 2923373Peng 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 17052399Zeybek 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 18045296Shedeed 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 20697704Sears MR. Trends in the prevalence of asthma. Chest. 2014 Feb;145(2):219-225. doi: 10.1378/chest.13-2059.
PubMed 24493506
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Biomarkers and the Left and Right Ventricular Systolic and Diastolic Function in Asthmatic Children in Assuit University Hospital
- ClinicalTrials.gov ID
- NCT05985720
- Acronym / sponsor ID
- Asthmatic children
- Conditions
- Ventricular Dysfunction, Asthma in Children
- Keywords
- asthma, cardiac affection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of cardiac biomarkers and the left and right ventricular systolic and diastolic function in asthmatic children in Assuit university hospital
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children aged from 5 years to 15 years diagnosed as bronchial asthma
Key inclusion criteria (1 listed)
- all pediatric cases between the age of 5 -15years with acute severe bronchial asthma who were admitted in pediatric emergency care unit
Key exclusion criteria (4 listed)
- Children with congenital or acquired heart diseases
- Foreign body aspiration .
- Chest infections
- Tuberculosis or pneumonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to identify the relation between asthmatic children and cardiac function
Time frame: Baseline
relation between asthma and cardiac function
to identify the relation between asthmatic children and myocardial dysfunction
Time frame: Baseline
relation between asthma and myocardial dysfunction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 2923373Rodriguez-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.
- Background: PubMed 17052399Peng 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.
- Background: PubMed 18045296Zeybek 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.
- Background: PubMed 20697704Shedeed 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.
- Background: PubMed 24493506Sears MR. Trends in the prevalence of asthma. Chest. 2014 Feb;145(2):219-225. doi: 10.1378/chest.13-2059.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Dysfunction and Asthma in Children, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to identify the relation between asthmatic children and cardiac function (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05985720, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.