Right Ventricular FunctionNCT06134947
Assessment of Right Ventricular Function Among Children With Chronic Lung Disease
An observational study of Right Ventricular Function, run by Assiut University.
Trial summary
A Pediatric Chronic lung disease (CLD) is an abroad term that encompasses a heterogeneous group of different clinicopathological disorders that advance slowly over months or years. They can broadly be divided into two groups: those with a known cause and those without. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Right Ventricular Function
- What is being tested?
- Echocardiographic examination
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to Feb 2025
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Sample Size Calculation: The sample size will be determined using epi-infoVersion 7 based on the following prerequisites: * Confidence level = 95% * Expected frequency of Chronic Respiratory Disease = 4.9%. * Confidence limit =5% * Population size = 10000. * Sample size (n) =75 patients as case group A total of seventy - five participants will be selected to be included at the study (group A=75 patients as case group (children with Chronic Respiratory Disease) , group B=75 children as control group (children with no Chronic Respiratory Disease). Including: 31 patients with bronchial asthma. 22 patients with interstitial pulmonary fibrosis. 22 patients with cystic fibrosis.
Who may be able to join
- Children have aged from 7 years to 18 years.
- Patients diagnosed with chronic lung disease at pediatric pulmonology unit by chest radiograph, computerized topography (CT) chest finding, sweat chloride test and pulmonary function tests.
- A total of seventy - five participants will be selected to be included at the study (group A=75 patients as case group (children with Chronic Respiratory Disease) , group B=75 children as control group (children with no Chronic Respiratory Disease).
- Including:
- 31 patients with bronchial asthma. 22 patients with interstitial pulmonary fibrosis. 22 patients with cystic fibrosis.
Who cannot join
- Congenital heart disease and Acquired heart diseases.
Trial locations and contacts
No sites are listed yet.
Ghada Mahmoud, prof contact
About this study
A Pediatric Chronic lung disease (CLD) is an abroad term that encompasses a heterogeneous group of different clinicopathological disorders that advance slowly over months or years. They can broadly be divided into two groups: those with a known cause and those without. Cystic fibrosis, broncho-pulmonary dysplasia or lung of prematurity, asthma, chronic gastro esophageal reflux/aspiration pneumonitis, and constrictive obliterative bronchiolitis, chronic infection, and hypersensitivity pneumonitis are all included in the first group. The second group is subdivided into primary pulmonary diseases (idiopathic interstitial pneumonia, persistent tachypnea of infancy associated with neuroendocrine cell hyperplasia, pulmonary lymphatic and vascular disorders, etc.) and systemic diseases with a pulmonary manifestation (e.g., Langerhans cell histio- cytosis, vasculities, and granulomatosis) Asthma is a chronic inflammatory disease of the airways which is related to airway obstruction, hyper responsiveness and characterized recurrent wheezing, coughing and breathlessness Asthma, recurrent hypoxemia, and hypercarbia, together with various mediators and cytokines released due to chronic inflammation, lead to pulmonary vasoconstriction Exaggerated respiratory efforts in asthmatic patients may increase intrathoracic pressure, which may increase right-ventricular (RV) afterload. Consequently, pulmonary hypertension may develop, which could then lead to RV hypertrophy and/or dilatation There are lacks of information's about right ventricular (RV) function in children with chronic lung diseases so in this study the RV systolic function will be evaluated. Systolic right ventricular (RV) function is an important predictor in the course of heart disease such as in pulmonary hypertension .The European Society of Cardiology and the American Society of Echocardiography recommend the use of tissue Doppler imaging for the evaluation of both diastolic and systolic functions .
Read the detailed description
A Pediatric Chronic lung disease (CLD) is an abroad term that encompasses a heterogeneous group of different clinicopathological disorders that advance slowly over months or years . They can broadly be divided into two groups: those with a known cause and those without. Cystic fibrosis, bronchopulmonary dysplasia or lung of prematurity, asthma, chronic gastro esophageal reflux/aspiration pneumonitis, and constrictive obliterative bronchiolitis, chronic infection, and hypersensitivity pneumonitis are all included in the first group. The second group is subdivided into primary pulmonary diseases (idiopathic interstitial pneumonia, persistent tachypnea of infancy associated with neuroendocrine cell hyperplasia, pulmonary lymphatic and vascular disorders, etc.) and systemic diseases with a pulmonary manifestation (e.g., Langerhans cell histiocytosis, vasculitis's, and granulomatosis) .
Asthma is a chronic inflammatory disease of the airways which is related to airway obstruction, hyper responsiveness and characterized recurrent wheezing, coughing and breathlessness .
Asthma, recurrent hypoxemia, and hypercarbia, together with various mediators and cytokines released due to chronic inflammation, lead to pulmonary vasoconstriction . Exaggerated respiratory efforts in asthmatic patients may increase intrathoracic pressure, which may increase right-ventricular (RV) afterload. Consequently, pulmonary hypertension may develop, which could then lead to RV hypertrophy and/or dilatation .
Blood viscosity from polycythemia secondary to hypoxia also plays a role in the development of pulmonary hypertension.
Patients with chronic lung diseases develop pulmonary hypertension (and core-pulmonal in severe cases) because of the recurrent hypoxia and chronic inflammation this results in right heart enlargement and ventricular hypertrophy .
The initial insult in congenital diaphragmatic hernia (CDH) occurs during embryogenesis, resulting in aberrant bilateral pulmonary parenchymal and cardiovascular development, followed by ongoing inhibition of growth secondary to compression by abdominal contents. These developmental abnormalities contribute to the clinical phenotypes in CDH, with evidence of pulmonary hypoplasia, pulmonary hypertension, and ventricular dysfunction all contributing to morbidity and mortality .
According to the Cystic Fibrosis Foundation Patient Registry (CFFPR), the United States has over 30,000 people living with CF (> 70,000 worldwide) with roughly 1,000 new cases of CF diagnosed every year.
This disease primarily affects the respiratory system and the gastrointestinal system. However, recent studies suggest a direct or indirect involvement of the cardiovascular system. The destruction of lung parenchyma and pulmonary vasoconstriction due to chronic hypoxemia may result in pulmonary hypertension causing cor pulmonale. Some studies imply that the CFTR protein is also expressed in cardiac myocytes, including both atrial and ventricular myocytes .
The European Society of Cardiology and the American Society of Echocardiography recommend the use of tissue Doppler imaging for the evaluation of both diastolic and systolic functions .
However, irregular shape of the right ventricle, its retrosternal location, and the frequent coexistence of lung hyperinflation make standard "gray-scale" imaging suboptimal for routine assessment of the right ventricle .
There are lacks of information's about right ventricular (RV) function in children with chronic lung diseases so in this study the investigator will evaluate of the RV systolic function.
Systolic right ventricular (RV) function is an important predictor in the course of heart disease such as in pulmonary hypertension and RV infarction. However, one of its widely used parameters, RV ejection fraction (EF), is difficult to assess both with accuracy and ease. This is due to the complex geometrical shape of the RV.
Traditionally, RV fractional area or long-axis change measurements (FAC and FLC) by two-dimensional (2D) echocardiography have been employed, also lD parameters such as the tricuspid annular peak systolic excursion (TAPSE) . The advent of tissue Doppler imaging (TDI) has initiated long-axis function analysis of both ventricles difficult to obtain by conventional echocardiograph, whereby pulsed-wave TDI at the lateral tricuspid annulus allows the recording of RV peak myocardial contraction velocity (v)
- Conditions
- Right Ventricular Function
- Being tested
- Echocardiographic examination
- Keywords
- chronic lung disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic examinationOther
Also called Echo Doppler study for right ventricular function
Standard 2D echocardiographic evaluation of right ventricle systolic function will be performed as follows:
- Tricuspid annular peak systolic excursion (TAPSE) will be measured by placing M- mode cursor through tricuspid annulus and measuring the amount of longitudinal motion of the annulus at the peak systole in the longitudinal apical 4chamber view, TAPSE <-2 Z Score is considered abnormal .
- Tricuspid annular peak systolic velocity (TAPSV) by tissue Doppler <-2 Z Score is considered abnormal.
Through Tissue Doppler Imaging values of right ventricle will be obtained from the apical four -chamber view using a sample volume placed at the lateral corner of the tricuspid annulus. Peak systolic annular velocity (Ś).
| Study group | Role | What they receive |
|---|---|---|
| Group A | group A=75 patients as case group (children with Chronic Respiratory Disease) Receives: Other: Echocardiographic examination | |
| Group B | group B=75 children as control group (children with no Chronic Respiratory Disease). Receives: Other: Echocardiographic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular function evaluation among children with chronic Lung disease
Right ventricular function evaluation among children with chronic Lung disease through tricuspid annular peak systolic excursion (TAPSE) and tricuspid annular peak systolic velocity (TAPSV) by tissue Doppler
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Right Ventricular FunctionStudies 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
- Retrospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khalaf Abd El Hamid Abdullah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134947
- Sponsor's protocol ID
- Right Ventricular Function in
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Horak F, Doberer D, Eber E, Horak E, Pohl W, Riedler J, Szepfalusi Z, Wantke F, Zacharasiewicz A, Studnicka M. Diagnosis and management of asthma - Statement on the 2015 GINA Guidelines. Wien Klin Wochenschr. 2016 Aug;128(15-16):541-54. doi: 10.1007/s00508-016-1019-4. Epub 2016 Jul 1.
PubMed 27370268Massoud TF, Hademenos GJ, De Salles AA, Solberg TD. Experimental radiosurgery simulations using a theoretical model of cerebral arteriovenous malformations. Stroke. 2000 Oct;31(10):2466-77. doi: 10.1161/01.str.31.10.2466.
PubMed 11022081Han R, Bansal D, Miyake K, Muniz VP, Weiss RM, McNeil PL, Campbell KP. Dysferlin-mediated membrane repair protects the heart from stress-induced left ventricular injury. J Clin Invest. 2007 Jul;117(7):1805-13. doi: 10.1172/JCI30848.
PubMed 17607357Nagueh SF, Appleton CP, Gillebert TC, Marino PN, Oh JK, Smiseth OA, Waggoner AD, Flachskampf FA, Pellikka PA, Evangelisa A. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. Eur J Echocardiogr. 2009 Mar;10(2):165-93. doi: 10.1093/ejechocard/jep007. No abstract available.
PubMed 19270053Patel N, Massolo AC, Kipfmueller F. Congenital diaphragmatic hernia-associated cardiac dysfunction. Semin Perinatol. 2020 Feb;44(1):151168. doi: 10.1053/j.semperi.2019.07.007. Epub 2019 Jul 30.
PubMed 31420110Warth JD, Collier ML, Hart P, Geary Y, Gelband CH, Chapman T, Horowitz B, Hume JR. CFTR chloride channels in human and simian heart. Cardiovasc Res. 1996 Apr;31(4):615-24.
PubMed 8689654Timmusk S, Paalme V, Pavlicek T, Bergquist J, Vangala A, Danilas T, Nevo E. Bacterial distribution in the rhizosphere of wild barley under contrasting microclimates. PLoS One. 2011 Mar 23;6(3):e17968. doi: 10.1371/journal.pone.0017968.
PubMed 21448272Mejza F, Gnatiuc L, Buist AS, Vollmer WM, Lamprecht B, Obaseki DO, Nastalek P, Nizankowska-Mogilnicka E, Burney PGJ; BOLD collaborators; BOLD study collaborators. Prevalence and burden of chronic bronchitis symptoms: results from the BOLD study. Eur Respir J. 2017 Nov 22;50(5):1700621. doi: 10.1183/13993003.00621-2017. Print 2017 Nov.
PubMed 29167298Koestenberger M, Ravekes W, Everett AD, Stueger HP, Heinzl B, Gamillscheg A, Cvirn G, Boysen A, Fandl A, Nagel B. Right ventricular function in infants, children and adolescents: reference values of the tricuspid annular plane systolic excursion (TAPSE) in 640 healthy patients and calculation of z score values. J Am Soc Echocardiogr. 2009 Jun;22(6):715-9. doi: 10.1016/j.echo.2009.03.026. Epub 2009 May 7.
PubMed 19423286
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Right Ventricular Function Among Children With Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT06134947
- Acronym / sponsor ID
- Right Ventricular Function in
- Conditions
- Right Ventricular Function
- Keywords
- chronic lung disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 18 Nov 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.
A Pediatric Chronic lung disease (CLD) is an abroad term that encompasses a heterogeneous group of different clinicopathological disorders that advance slowly over months or years. They can broadly be divided into two groups: those with a known cause and those without. Cystic fibrosis, broncho-pulmonary dysplasia or lung of prematurity, asthma, chronic gastro esophageal reflux/aspiration pneumonitis, and constrictive obliterative bronchiolitis, chronic infection, and hypersensitivity pneumonitis are all included in the first group. The second group is subdivided into primary pulmonary diseases (idiopathic interstitial pneumonia, persistent tachypnea of infancy associated with neuroendocrine cell hyperplasia, pulmonary lymphatic and vascular disorders, etc.) and systemic diseases with a pulmonary manifestation (e.g., Langerhans cell histio- cytosis, vasculities, and granulomatosis) Asthma is a chronic inflammatory disease of the airways which is related to airway obstruction, hyper responsiveness and characterized recurrent wheezing, coughing and breathlessness Asthma, recurrent hypoxemia, and hypercarbia, together with various mediators and cytokines released due to chronic inflammation, lead to pulmonary vasoconstriction Exaggerated respiratory efforts in asthmatic patients may increase intrathoracic pressure, which may increase right-ventricular (RV) afterload. Consequently, pulmonary hypertension may develop, which could then lead to RV hypertrophy and/or dilatation There are lacks of information's about right ventricular (RV) function in children with chronic lung diseases so in this study the RV systolic function will be evaluated. Systolic right ventricular (RV) function is an important predictor in the course of heart disease such as in pulmonary hypertension .The European Society of Cardiology and the American Society of Echocardiography recommend the use of tissue Doppler imaging for the evaluation of both diastolic and systolic functions .
Detailed description
A Pediatric Chronic lung disease (CLD) is an abroad term that encompasses a heterogeneous group of different clinicopathological disorders that advance slowly over months or years . They can broadly be divided into two groups: those with a known cause and those without. Cystic fibrosis, bronchopulmonary dysplasia or lung of prematurity, asthma, chronic gastro esophageal reflux/aspiration pneumonitis, and constrictive obliterative bronchiolitis, chronic infection, and hypersensitivity pneumonitis are all included in the first group. The second group is subdivided into primary pulmonary diseases (idiopathic interstitial pneumonia, persistent tachypnea of infancy associated with neuroendocrine cell hyperplasia, pulmonary lymphatic and vascular disorders, etc.) and systemic diseases with a pulmonary manifestation (e.g., Langerhans cell histiocytosis, vasculitis's, and granulomatosis) .
Asthma is a chronic inflammatory disease of the airways which is related to airway obstruction, hyper responsiveness and characterized recurrent wheezing, coughing and breathlessness .
Asthma, recurrent hypoxemia, and hypercarbia, together with various mediators and cytokines released due to chronic inflammation, lead to pulmonary vasoconstriction . Exaggerated respiratory efforts in asthmatic patients may increase intrathoracic pressure, which may increase right-ventricular (RV) afterload. Consequently, pulmonary hypertension may develop, which could then lead to RV hypertrophy and/or dilatation .
Blood viscosity from polycythemia secondary to hypoxia also plays a role in the development of pulmonary hypertension.
Patients with chronic lung diseases develop pulmonary hypertension (and core-pulmonal in severe cases) because of the recurrent hypoxia and chronic inflammation this results in right heart enlargement and ventricular hypertrophy .
The initial insult in congenital diaphragmatic hernia (CDH) occurs during embryogenesis, resulting in aberrant bilateral pulmonary parenchymal and cardiovascular development, followed by ongoing inhibition of growth secondary to compression by abdominal contents. These developmental abnormalities contribute to the clinical phenotypes in CDH, with evidence of pulmonary hypoplasia, pulmonary hypertension, and ventricular dysfunction all contributing to morbidity and mortality .
According to the Cystic Fibrosis Foundation Patient Registry (CFFPR), the United States has over 30,000 people living with CF (> 70,000 worldwide) with roughly 1,000 new cases of CF diagnosed every year.
This disease primarily affects the respiratory system and the gastrointestinal system. However, recent studies suggest a direct or indirect involvement of the cardiovascular system. The destruction of lung parenchyma and pulmonary vasoconstriction due to chronic hypoxemia may result in pulmonary hypertension causing cor pulmonale. Some studies imply that the CFTR protein is also expressed in cardiac myocytes, including both atrial and ventricular myocytes .
The European Society of Cardiology and the American Society of Echocardiography recommend the use of tissue Doppler imaging for the evaluation of both diastolic and systolic functions .
However, irregular shape of the right ventricle, its retrosternal location, and the frequent coexistence of lung hyperinflation make standard "gray-scale" imaging suboptimal for routine assessment of the right ventricle .
There are lacks of information's about right ventricular (RV) function in children with chronic lung diseases so in this study the investigator will evaluate of the RV systolic function.
Systolic right ventricular (RV) function is an important predictor in the course of heart disease such as in pulmonary hypertension and RV infarction. However, one of its widely used parameters, RV ejection fraction (EF), is difficult to assess both with accuracy and ease. This is due to the complex geometrical shape of the RV.
Traditionally, RV fractional area or long-axis change measurements (FAC and FLC) by two-dimensional (2D) echocardiography have been employed, also lD parameters such as the tricuspid annular peak systolic excursion (TAPSE) . The advent of tissue Doppler imaging (TDI) has initiated long-axis function analysis of both ventricles difficult to obtain by conventional echocardiograph, whereby pulsed-wave TDI at the lateral tricuspid annulus allows the recording of RV peak myocardial contraction velocity (v)
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Echocardiographic examinationgroup A=75 patients as case group (children with Chronic Respiratory Disease) |
| Group B | – | Other: Echocardiographic examinationgroup B=75 children as control group (children with no Chronic Respiratory Disease). |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Sample Size Calculation: The sample size will be determined using epi-infoVersion 7 based on the following prerequisites: * Confidence level = 95% * Expected frequency of Chronic Respiratory Disease = 4.9%. * Confidence limit =5% * Population size = 10000. * Sample size (n) =75 patients as case group A total of seventy - five participants will be selected to be included at the study (group A=75 patients as case group (children with Chronic Respiratory Disease) , group B=75 children as control group (children with no Chronic Respiratory Disease). Including: 31 patients with bronchial asthma. 22 patients with interstitial pulmonary fibrosis. 22 patients with cystic fibrosis.
Key inclusion criteria (5 listed)
- Children have aged from 7 years to 18 years.
- Patients diagnosed with chronic lung disease at pediatric pulmonology unit by chest radiograph, computerized topography (CT) chest finding, sweat chloride test and pulmonary function tests.
- A total of seventy - five participants will be selected to be included at the study (group A=75 patients as case group (children with Chronic Respiratory Disease) , group B=75 children as control group (children with no Chronic Respiratory Disease).
- 31 patients with bronchial asthma. 22 patients with interstitial pulmonary fibrosis. 22 patients with cystic fibrosis.
Key exclusion criteria (1 listed)
- Congenital heart disease and Acquired heart diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiographic examinationAlso: Echo Doppler study for right ventricular functionStandard 2D echocardiographic evaluation of right ventricle systolic function will be performed as follows: * Tricuspid annular peak systolic excursion (TAPSE) will be measured by placing M- mode cursor through tricuspid annulus and measuring the amount of longitudinal motion of the annulus at the peak systole in the longitudinal apical 4chamber view, TAPSE <-2 Z Score is considered abnormal . * Tricuspid annular peak systolic velocity (TAPSV) by tissue Doppler <-2 Z Score is considered abnormal. Through Tissue Doppler Imaging values of right ventricle will be obtained from the apical four -chamber view using a sample volume placed at the lateral corner of the tricuspid annulus. Peak systolic annular velocity (Ś). | Other | Group A, Group B |
Primary outcome
Right ventricular function evaluation among children with chronic Lung disease
Time frame: 1 year
Right ventricular function evaluation among children with chronic Lung disease through tricuspid annular peak systolic excursion (TAPSE) and tricuspid annular peak systolic velocity (TAPSV) by tissue Doppler
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 27370268Horak F, Doberer D, Eber E, Horak E, Pohl W, Riedler J, Szepfalusi Z, Wantke F, Zacharasiewicz A, Studnicka M. Diagnosis and management of asthma - Statement on the 2015 GINA Guidelines. Wien Klin Wochenschr. 2016 Aug;128(15-16):541-54. doi: 10.1007/s00508-016-1019-4. Epub 2016 Jul 1.
- Background: PubMed 11022081Massoud TF, Hademenos GJ, De Salles AA, Solberg TD. Experimental radiosurgery simulations using a theoretical model of cerebral arteriovenous malformations. Stroke. 2000 Oct;31(10):2466-77. doi: 10.1161/01.str.31.10.2466.
- Background: PubMed 17607357Han R, Bansal D, Miyake K, Muniz VP, Weiss RM, McNeil PL, Campbell KP. Dysferlin-mediated membrane repair protects the heart from stress-induced left ventricular injury. J Clin Invest. 2007 Jul;117(7):1805-13. doi: 10.1172/JCI30848.
- Background: PubMed 19270053Nagueh SF, Appleton CP, Gillebert TC, Marino PN, Oh JK, Smiseth OA, Waggoner AD, Flachskampf FA, Pellikka PA, Evangelisa A. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. Eur J Echocardiogr. 2009 Mar;10(2):165-93. doi: 10.1093/ejechocard/jep007. No abstract available.
- Background: PubMed 31420110Patel N, Massolo AC, Kipfmueller F. Congenital diaphragmatic hernia-associated cardiac dysfunction. Semin Perinatol. 2020 Feb;44(1):151168. doi: 10.1053/j.semperi.2019.07.007. Epub 2019 Jul 30.
- Background: PubMed 8689654Warth JD, Collier ML, Hart P, Geary Y, Gelband CH, Chapman T, Horowitz B, Hume JR. CFTR chloride channels in human and simian heart. Cardiovasc Res. 1996 Apr;31(4):615-24.
- Background: PubMed 21448272Timmusk S, Paalme V, Pavlicek T, Bergquist J, Vangala A, Danilas T, Nevo E. Bacterial distribution in the rhizosphere of wild barley under contrasting microclimates. PLoS One. 2011 Mar 23;6(3):e17968. doi: 10.1371/journal.pone.0017968.
- Background: PubMed 29167298Mejza F, Gnatiuc L, Buist AS, Vollmer WM, Lamprecht B, Obaseki DO, Nastalek P, Nizankowska-Mogilnicka E, Burney PGJ; BOLD collaborators; BOLD study collaborators. Prevalence and burden of chronic bronchitis symptoms: results from the BOLD study. Eur Respir J. 2017 Nov 22;50(5):1700621. doi: 10.1183/13993003.00621-2017. Print 2017 Nov.
- Background: PubMed 19423286Koestenberger M, Ravekes W, Everett AD, Stueger HP, Heinzl B, Gamillscheg A, Cvirn G, Boysen A, Fandl A, Nagel B. Right ventricular function in infants, children and adolescents: reference values of the tricuspid annular plane systolic excursion (TAPSE) in 640 healthy patients and calculation of z score values. J Am Soc Echocardiogr. 2009 Jun;22(6):715-9. doi: 10.1016/j.echo.2009.03.026. Epub 2009 May 7.
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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.
Ghada Mahmoud, prof contact
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Function, 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 5 inclusion and 1 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 18 Nov 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?
Contact Mohamed Abdel-Hamed, as (+201027088385, dr1khalaf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular function evaluation among children with chronic Lung disease (time frame: 1 year). 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 NCT06134947, which also lists 9 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 18 Nov 2023.