Right Ventricular DysfunctionNCT04960085
Role of Echocardiography in the Assessment of Right Ventricular Function in the Pediatric Population With Valvular Pulmonary Stenosis.
An observational study of Right Ventricular Dysfunction, run by Assiut University.
Trial summary
Correct assessment of right ventricular function by transthoracic echocardiographic examination in pediatric patients with congenital valvular pulmonary stenosis after Percutaneous Balloon Pulmonary Valvuloplasty Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Right Ventricular Dysfunction
- What is being tested?
- echocardiography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Jul 2021to 2 Aug 2022
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients with valvular pulmonary stenosis who will undergo trans cutaneous pulmonary valvuloplasty
Who may be able to join
- All pediatric patients with congenital valvular pulmonary stenosis attending echocardiographic outpatient clinic of Assuit University children hospital aged from one month to18 years old
Who cannot join
- Age less than one month and older than 18 years. Patients with infundibular and supravalvular pulmonary stenosis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Echocardiography in the Assessment of Right Ventricular Function in the Pediatric Population With Valvular Pulmonary Stenosis After Percutaneous Balloon Pulmonary Valvuoplasty.
Correct assessment of right ventricular function by transthoracic echocardiographic examination in pediatric patients with congenital valvular pulmonary stenosis after Percutaneous Balloon Pulmonary Valvuloplasty
Read the detailed description
The right ventricle plays an important role in the morbidity and mortality of patients presenting with signs and symptoms of cardiopulmonary disease. However, the systematic assessment of right heart function is not uniformly carried out. This is due partly to the enormous attention given to the evaluation of the left heart, a lack of familiarity with ultrasound techniques that can be used in imaging the right heart, and a paucity of ultrasound studies providing normal reference values of right heart size and function. In patients with CHD, the right ventricle (RV) may function as either the sub-pulmonary or the systemic ventricle as in transposition of great arteries (TGA). CHD more commonly affecting the right heart includes atrial septal defects (ASD), Tetralogy of Fallot (TOF), pulmonary stenosis (PS), Ebstein anomaly, arrhythmogenic right ventricular cardiomyopathy (ARVC), and pulmonary valve atresia. In many of these patients, prevention of "irreversible" right heart failure (RHF) will require timely corrective surgery or when not possible, surgical palliation . Congenital pulmonary valve stenosis is a common congenital heart disease. Isolated pulmonary valve stenosis comprises 8-10% of all congenital heart disease . While surgical pulmonary valvotomy has been available as a treatment since 1956, it requires a median sternotomy, use of cardiopulmonary bypass, and post-surgical ICU admission with multi-day hospitalization. Recognizing the potential advantages of a less invasive approach, the first attempts at percutaneous catheter-based dilation of stenotic pulmonary valves were performed in the 1950s. As the technique was refined and catheter and balloon technology have advanced, the results of balloon pulmonary valvuloplasty have improved and the approach has become the standard of care for treating pulmonary valve stenosis
- Conditions
- Right Ventricular Dysfunction
- Being tested
- echocardiography
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDevice
philips IE33
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between right ventricular dysfunction and severity of valvular pulmonary stenosis
tissue Doppler of the right ventricle before and after trans cutaneous pulmonary valvuloplasty
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start2 Jul 2021 (estimated)
- Primary completion2 Jul 2022 (estimated)
- Study completion2 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Right 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saad Abdelhafiz Abdelsalam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960085
- Sponsor's protocol ID
- echo in RV function
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pierpont ME, Basson CT, Benson DW Jr, Gelb BD, Giglia TM, Goldmuntz E, McGee G, Sable CA, Srivastava D, Webb CL; American Heart Association Congenital Cardiac Defects Committee, Council on Cardiovascular Disease in the Young. Genetic basis for congenital heart defects: current knowledge: a scientific statement from the American Heart Association Congenital Cardiac Defects Committee, Council on Cardiovascular Disease in the Young: endorsed by the American Academy of Pediatrics. Circulation. 2007 Jun 12;115(23):3015-38. doi: 10.1161/CIRCULATIONAHA.106.183056. Epub 2007 May 22.
PubMed 17519398Baumgartner H, Bonhoeffer P, De Groot NM, de Haan F, Deanfield JE, Galie N, Gatzoulis MA, Gohlke-Baerwolf C, Kaemmerer H, Kilner P, Meijboom F, Mulder BJ, Oechslin E, Oliver JM, Serraf A, Szatmari A, Thaulow E, Vouhe PR, Walma E; Task Force on the Management of Grown-up Congenital Heart Disease of the European Society of Cardiology (ESC); Association for European Paediatric Cardiology (AEPC); ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). Eur Heart J. 2010 Dec;31(23):2915-57. doi: 10.1093/eurheartj/ehq249. Epub 2010 Aug 27. No abstract available.
PubMed 20801927Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available.
PubMed 18378625Haddad F, Hunt SA, Rosenthal DN, Murphy DJ. Right ventricular function in cardiovascular disease, part I: Anatomy, physiology, aging, and functional assessment of the right ventricle. Circulation. 2008 Mar 18;117(11):1436-48. doi: 10.1161/CIRCULATIONAHA.107.653576. No abstract available.
PubMed 18347220Hornung TS, Bernard EJ, Jaeggi ET, Howman-Giles RB, Celermajer DS, Hawker RE. Myocardial perfusion defects and associated systemic ventricular dysfunction in congenitally corrected transposition of the great arteries. Heart. 1998 Oct;80(4):322-6. doi: 10.1136/hrt.80.4.322.
PubMed 9875104Hauser M, Bengel FM, Hager A, Kuehn A, Nekolla SG, Kaemmerer H, Schwaiger M, Hess J. Impaired myocardial blood flow and coronary flow reserve of the anatomical right systemic ventricle in patients with congenitally corrected transposition of the great arteries. Heart. 2003 Oct;89(10):1231-5. doi: 10.1136/heart.89.10.1231.
PubMed 12975428Davlouros PA, Niwa K, Webb G, Gatzoulis MA. The right ventricle in congenital heart disease. Heart. 2006 Apr;92 Suppl 1(Suppl 1):i27-38. doi: 10.1136/hrt.2005.077438.
PubMed 16543599Cheung MM, Smallhorn JF, Redington AN, Vogel M. The effects of changes in loading conditions and modulation of inotropic state on the myocardial performance index: comparison with conductance catheter measurements. Eur Heart J. 2004 Dec;25(24):2238-42. doi: 10.1016/j.ehj.2004.07.034.
PubMed 15589642Vogel M, Sponring J, Cullen S, Deanfield JE, Redington AN. Regional wall motion and abnormalities of electrical depolarization and repolarization in patients after surgical repair of tetralogy of Fallot. Circulation. 2001 Mar 27;103(12):1669-73. doi: 10.1161/01.cir.103.12.1669.
PubMed 11273995Vogel M, Schmidt MR, Kristiansen SB, Cheung M, White PA, Sorensen K, Redington AN. Validation of myocardial acceleration during isovolumic contraction as a novel noninvasive index of right ventricular contractility: comparison with ventricular pressure-volume relations in an animal model. Circulation. 2002 Apr 9;105(14):1693-9. doi: 10.1161/01.cir.0000013773.67850.ba.
PubMed 11940549Vogel M, Derrick G, White PA, Cullen S, Aichner H, Deanfield J, Redington AN. Systemic ventricular function in patients with transposition of the great arteries after atrial repair: a tissue Doppler and conductance catheter study. J Am Coll Cardiol. 2004 Jan 7;43(1):100-6. doi: 10.1016/j.jacc.2003.06.018.
PubMed 14715190
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Echocardiography in the Assessment of Right Ventricular Function in the Pediatric Population With Valvular Pulmonary Stenosis After Percutaneous Balloon Pulmonary Valvuoplasty.
- ClinicalTrials.gov ID
- NCT04960085
- Acronym / sponsor ID
- echo in RV function
- Conditions
- Right Ventricular Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Jul 2021 (estimated)
- Primary completion
- 2 Jul 2022 (estimated)
- Study completion
- 2 Aug 2022 (estimated)
- First posted
- 13 Jul 2021 (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.
Correct assessment of right ventricular function by transthoracic echocardiographic examination in pediatric patients with congenital valvular pulmonary stenosis after Percutaneous Balloon Pulmonary Valvuloplasty
Detailed description
The right ventricle plays an important role in the morbidity and mortality of patients presenting with signs and symptoms of cardiopulmonary disease. However, the systematic assessment of right heart function is not uniformly carried out. This is due partly to the enormous attention given to the evaluation of the left heart, a lack of familiarity with ultrasound techniques that can be used in imaging the right heart, and a paucity of ultrasound studies providing normal reference values of right heart size and function. In patients with CHD, the right ventricle (RV) may function as either the sub-pulmonary or the systemic ventricle as in transposition of great arteries (TGA). CHD more commonly affecting the right heart includes atrial septal defects (ASD), Tetralogy of Fallot (TOF), pulmonary stenosis (PS), Ebstein anomaly, arrhythmogenic right ventricular cardiomyopathy (ARVC), and pulmonary valve atresia. In many of these patients, prevention of "irreversible" right heart failure (RHF) will require timely corrective surgery or when not possible, surgical palliation . Congenital pulmonary valve stenosis is a common congenital heart disease. Isolated pulmonary valve stenosis comprises 8-10% of all congenital heart disease . While surgical pulmonary valvotomy has been available as a treatment since 1956, it requires a median sternotomy, use of cardiopulmonary bypass, and post-surgical ICU admission with multi-day hospitalization. Recognizing the potential advantages of a less invasive approach, the first attempts at percutaneous catheter-based dilation of stenotic pulmonary valves were performed in the 1950s. As the technique was refined and catheter and balloon technology have advanced, the results of balloon pulmonary valvuloplasty have improved and the approach has become the standard of care for treating pulmonary valve stenosis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients with valvular pulmonary stenosis who will undergo trans cutaneous pulmonary valvuloplasty
Key inclusion criteria (1 listed)
- All pediatric patients with congenital valvular pulmonary stenosis attending echocardiographic outpatient clinic of Assuit University children hospital aged from one month to18 years old
Key exclusion criteria (1 listed)
- Age less than one month and older than 18 years. Patients with infundibular and supravalvular pulmonary stenosis
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 |
|---|---|---|
| echocardiographyphilips IE33 | Device | – |
Primary outcome
correlation between right ventricular dysfunction and severity of valvular pulmonary stenosis
Time frame: baseline
tissue Doppler of the right ventricle before and after trans cutaneous pulmonary valvuloplasty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Background: PubMed 17519398Pierpont ME, Basson CT, Benson DW Jr, Gelb BD, Giglia TM, Goldmuntz E, McGee G, Sable CA, Srivastava D, Webb CL; American Heart Association Congenital Cardiac Defects Committee, Council on Cardiovascular Disease in the Young. Genetic basis for congenital heart defects: current knowledge: a scientific statement from the American Heart Association Congenital Cardiac Defects Committee, Council on Cardiovascular Disease in the Young: endorsed by the American Academy of Pediatrics. Circulation. 2007 Jun 12;115(23):3015-38. doi: 10.1161/CIRCULATIONAHA.106.183056. Epub 2007 May 22.
- Background: PubMed 20801927Baumgartner H, Bonhoeffer P, De Groot NM, de Haan F, Deanfield JE, Galie N, Gatzoulis MA, Gohlke-Baerwolf C, Kaemmerer H, Kilner P, Meijboom F, Mulder BJ, Oechslin E, Oliver JM, Serraf A, Szatmari A, Thaulow E, Vouhe PR, Walma E; Task Force on the Management of Grown-up Congenital Heart Disease of the European Society of Cardiology (ESC); Association for European Paediatric Cardiology (AEPC); ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). Eur Heart J. 2010 Dec;31(23):2915-57. doi: 10.1093/eurheartj/ehq249. Epub 2010 Aug 27. No abstract available.
- Background: PubMed 18378625Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available.
- Background: PubMed 18347220Haddad F, Hunt SA, Rosenthal DN, Murphy DJ. Right ventricular function in cardiovascular disease, part I: Anatomy, physiology, aging, and functional assessment of the right ventricle. Circulation. 2008 Mar 18;117(11):1436-48. doi: 10.1161/CIRCULATIONAHA.107.653576. No abstract available.
- Background: PubMed 9875104Hornung TS, Bernard EJ, Jaeggi ET, Howman-Giles RB, Celermajer DS, Hawker RE. Myocardial perfusion defects and associated systemic ventricular dysfunction in congenitally corrected transposition of the great arteries. Heart. 1998 Oct;80(4):322-6. doi: 10.1136/hrt.80.4.322.
- Background: PubMed 12975428Hauser M, Bengel FM, Hager A, Kuehn A, Nekolla SG, Kaemmerer H, Schwaiger M, Hess J. Impaired myocardial blood flow and coronary flow reserve of the anatomical right systemic ventricle in patients with congenitally corrected transposition of the great arteries. Heart. 2003 Oct;89(10):1231-5. doi: 10.1136/heart.89.10.1231.
- Background: PubMed 16543599Davlouros PA, Niwa K, Webb G, Gatzoulis MA. The right ventricle in congenital heart disease. Heart. 2006 Apr;92 Suppl 1(Suppl 1):i27-38. doi: 10.1136/hrt.2005.077438.
- Background: PubMed 15589642Cheung MM, Smallhorn JF, Redington AN, Vogel M. The effects of changes in loading conditions and modulation of inotropic state on the myocardial performance index: comparison with conductance catheter measurements. Eur Heart J. 2004 Dec;25(24):2238-42. doi: 10.1016/j.ehj.2004.07.034.
- Background: PubMed 11273995Vogel M, Sponring J, Cullen S, Deanfield JE, Redington AN. Regional wall motion and abnormalities of electrical depolarization and repolarization in patients after surgical repair of tetralogy of Fallot. Circulation. 2001 Mar 27;103(12):1669-73. doi: 10.1161/01.cir.103.12.1669.
- Background: PubMed 11940549Vogel M, Schmidt MR, Kristiansen SB, Cheung M, White PA, Sorensen K, Redington AN. Validation of myocardial acceleration during isovolumic contraction as a novel noninvasive index of right ventricular contractility: comparison with ventricular pressure-volume relations in an animal model. Circulation. 2002 Apr 9;105(14):1693-9. doi: 10.1161/01.cir.0000013773.67850.ba.
- Background: PubMed 14715190Vogel M, Derrick G, White PA, Cullen S, Aichner H, Deanfield J, Redington AN. Systemic ventricular function in patients with transposition of the great arteries after atrial repair: a tissue Doppler and conductance catheter study. J Am Coll Cardiol. 2004 Jan 7;43(1):100-6. doi: 10.1016/j.jacc.2003.06.018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Dysfunction, 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 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 13 Jul 2021. 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 Saad Abdelhafiz Abdelsalam, master degree (01007459576, saadabdelsalam13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between right ventricular dysfunction and severity of valvular pulmonary stenosis (time frame: baseline). 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 NCT04960085, which also lists 11 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 13 Jul 2021.