Congenital Heart DefectNCT04964531
Effect of PDA Closure on the Left Ventricular Remodeling
An observational study of Congenital Heart Defect and Patent Ductus Arteriosus, run by Ahmed Mohamed Moheb El-Din.
Trial summary
failure of closure of the ductus arteriosus after birth results in a congenital anomaly known as patent ductus arteriosus. The large ductus can induce left side heart remodeling changes which could interfere with the normal cardiac function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Defect, Patent Ductus Arteriosus
- What is being tested?
- speckle tracking echocardiography
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Feb 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: the study population will include all patients diagnosed as having patent ductus arteriosus and this ductus either hemodynamically insignificant but with audible murmur or this duct causes left heart volume overload symptoms
Who may be able to join
- all patients who are candidate for transcatheter PDA closure.
Who cannot join
- Patients with PDA dependent pulmonary circulation.
- Patients with small sized PDA which is silent by auscultation.
- Patients with large sized PDA which is unsuitable for Trans-catheter closure .
- Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
- Patients with active infection or active infective endarteritis.
- Patients refusing the study.
- Patients with DM, HTN and ischemic heart diseases.
- Patients with associated congenital or acquired cardiac lesions that may interfere with LV mechanics.
About this study
Official title: Left Ventricular Remodeling After Transcatheter Closure of the Patent Ductus Arteriosus. Comparative Study Between Different Age Groups
failure of closure of the ductus arteriosus after birth results in a congenital anomaly known as patent ductus arteriosus. The large ductus can induce left side heart remodeling changes which could interfere with the normal cardiac function.
Read the detailed description
Patent ductus arteriosus (PDA) is a congenital heart disease that represents 6-11% of all congenital heart diseases and is due to failure of spontaneous closure of a normal foetal duct called ductus arteriosus, that is a duct connecting the left pulmonary artery to the aorta, and it may result in LV volume overload , pulmonary overflow that may end with development of Eisenmenger syndrome. LV volume overload of the big ductus induce left heart remodeling changes in form of LA and LV dilatation, and LV hypertrophy to compensate for the increased wall stress. Some patients compensate well and remain asymptomatic, while others can't and develop manifestations of LV systolic dysfunction .
Traditional echocardiography is the main diagnostic tool for the PDA and assessment of its hemodynamic effect on the heart. speckle tracking echocardiography ( STE) is a relatively novel tool that can assess the LV function by tracking the speckles of the grey scale 2D images. Recent studies revealed good correlation between the LVEF measured by traditional echocardiography and global longitudinal strain (GLS) measured by STE , in addition to detection of subtle myocardial dysfunction by STE in patients with heart failure with preserved LVEF before frank LV systolic dysfunction is apparent clinically .
PDA closure should induce reverse remodelling with improvement of the left heart dimensions and function . Many studies in pediatrics showed deterioration of LVEF early after PDA closure followed by rapid recovery , while fewer studies showed late improvement of the LVEF in the adults .
- Conditions
- Congenital Heart Defect, Patent Ductus Arteriosus
- Being tested
- speckle tracking echocardiography
- Medical subject headings
- Heart Defects, Congenital, Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speckle tracking echocardiographyOther
before and after closure of the PDA , echocardiographic loops of the apical 4, 3 , and 2 chamber will be acquired then processed by special software for measuring the speckle movements in the longitudinal and short axis views
| Study group | Role | What they receive |
|---|---|---|
| Adults | group of adults includes all patients aging 19 years or more Receives: Other: speckle tracking echocardiography | |
| children | group of children includes all patients aging less than 19 years Receives: Other: speckle tracking echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of LV strain after transcatheter closure of the PDA
Assess the change of left ventricular longitudinal and circumferential strain by speckle tracking echocardiography after PDA closure, and compare this change between the children and adults.
Measured: at base line, within 48 hours after closure of the duct then at three and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Mohamed Moheb El-Din
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Mohamed Moheb El-Din, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964531
- Sponsor's protocol ID
- speckle tracking, PDA
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morton SU, Brodsky D. Fetal Physiology and the Transition to Extrauterine Life. Clin Perinatol. 2016 Sep;43(3):395-407. doi: 10.1016/j.clp.2016.04.001. Epub 2016 Jun 11.
PubMed 27524443Weir EK, Obreztchikova M, Vargese A, Cabrera JA, Peterson DA, Hong Z. Mechanisms of oxygen sensing: a key to therapy of pulmonary hypertension and patent ductus arteriosus. Br J Pharmacol. 2008 Oct;155(3):300-7. doi: 10.1038/bjp.2008.291. Epub 2008 Jul 21.
PubMed 18641675P S, Jose J, George OK. Contemporary outcomes of percutaneous closure of patent ductus arteriosus in adolescents and adults. Indian Heart J. 2018 Mar-Apr;70(2):308-315. doi: 10.1016/j.ihj.2017.08.001. Epub 2017 Aug 9.
PubMed 29716712Schneider DJ. The patent ductus arteriosus in term infants, children, and adults. Semin Perinatol. 2012 Apr;36(2):146-53. doi: 10.1053/j.semperi.2011.09.025.
PubMed 22414886Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. Eur J Echocardiogr. 2011 Mar;12(3):167-205. doi: 10.1093/ejechocard/jer021.
PubMed 21385887Mondillo S, Galderisi M, Mele D, Cameli M, Lomoriello VS, Zaca V, Ballo P, D'Andrea A, Muraru D, Losi M, Agricola E, D'Errico A, Buralli S, Sciomer S, Nistri S, Badano L; Echocardiography Study Group Of The Italian Society Of Cardiology (Rome, Italy). Speckle-tracking echocardiography: a new technique for assessing myocardial function. J Ultrasound Med. 2011 Jan;30(1):71-83. doi: 10.7863/jum.2011.30.1.71.
PubMed 21193707Edvardsen T, Helle-Valle T, Smiseth OA. Systolic dysfunction in heart failure with normal ejection fraction: speckle-tracking echocardiography. Prog Cardiovasc Dis. 2006 Nov-Dec;49(3):207-14. doi: 10.1016/j.pcad.2006.08.008.
PubMed 17084180Amoogzar H, Shakiba AM, Derakhshan D, Ajami G, Cheriki S, Borzouee M, Edraki MR, Mehdizadegan N. Evaluation of left ventricular function by tissue Doppler and speckle-derived strain rate echocardiography after percutaneous ductus closure. Pediatr Cardiol. 2015 Jan;36(1):219-25. doi: 10.1007/s00246-014-0989-0. Epub 2014 Aug 9.
PubMed 25107547Tilahun B, Tefera E. Transient left ventricular systolic dysfunction following surgical closure of large patent ductus arteriosus among children and adolescents operated at the cardiac centre, Ethiopia. J Cardiothorac Surg. 2013 May 31;8:139. doi: 10.1186/1749-8090-8-139.
PubMed 23721219Jeong YH, Yun TJ, Song JM, Park JJ, Seo DM, Koh JK, Lee SW, Kim MJ, Kang DH, Song JK. Left ventricular remodeling and change of systolic function after closure of patent ductus arteriosus in adults: device and surgical closure. Am Heart J. 2007 Sep;154(3):436-40. doi: 10.1016/j.ahj.2007.04.045.
PubMed 17719286Zhan Z, Guan L, Pan W, Zhang X, Zhang L, Zhou D, Ge J. Left ventricular size and function after percutaneous closure of patent ductus arteriosus in Chinese adults. Int J Cardiol. 2020 Sep 15;315:24-28. doi: 10.1016/j.ijcard.2020.04.060. Epub 2020 Apr 22.
PubMed 32333933Yasuhara J, Kuno T, Kumamoto T, Kojima T, Shimizu H, Yoshiba S, Kobayashi T, Sumitomo N. Comparison of transcatheter patent ductus arteriosus closure between children and adults. Heart Vessels. 2020 Nov;35(11):1605-1613. doi: 10.1007/s00380-020-01639-4. Epub 2020 Jun 3.
PubMed 32494943
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Remodeling After Transcatheter Closure of the Patent Ductus Arteriosus. Comparative Study Between Different Age Groups
- ClinicalTrials.gov ID
- NCT04964531
- Acronym / sponsor ID
- speckle tracking, PDA
- Conditions
- Congenital Heart Defect, Patent Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ahmed Mohamed Moheb El-DinUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 16 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.
failure of closure of the ductus arteriosus after birth results in a congenital anomaly known as patent ductus arteriosus. The large ductus can induce left side heart remodeling changes which could interfere with the normal cardiac function.
Detailed description
Patent ductus arteriosus (PDA) is a congenital heart disease that represents 6-11% of all congenital heart diseases and is due to failure of spontaneous closure of a normal foetal duct called ductus arteriosus, that is a duct connecting the left pulmonary artery to the aorta, and it may result in LV volume overload , pulmonary overflow that may end with development of Eisenmenger syndrome. LV volume overload of the big ductus induce left heart remodeling changes in form of LA and LV dilatation, and LV hypertrophy to compensate for the increased wall stress. Some patients compensate well and remain asymptomatic, while others can't and develop manifestations of LV systolic dysfunction .
Traditional echocardiography is the main diagnostic tool for the PDA and assessment of its hemodynamic effect on the heart. speckle tracking echocardiography ( STE) is a relatively novel tool that can assess the LV function by tracking the speckles of the grey scale 2D images. Recent studies revealed good correlation between the LVEF measured by traditional echocardiography and global longitudinal strain (GLS) measured by STE , in addition to detection of subtle myocardial dysfunction by STE in patients with heart failure with preserved LVEF before frank LV systolic dysfunction is apparent clinically .
PDA closure should induce reverse remodelling with improvement of the left heart dimensions and function . Many studies in pediatrics showed deterioration of LVEF early after PDA closure followed by rapid recovery , while fewer studies showed late improvement of the LVEF in the adults .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Other: speckle tracking echocardiographygroup of adults includes all patients aging 19 years or more |
| children | – | Other: speckle tracking echocardiographygroup of children includes all patients aging less than 19 years |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- the study population will include all patients diagnosed as having patent ductus arteriosus and this ductus either hemodynamically insignificant but with audible murmur or this duct causes left heart volume overload symptoms
Key inclusion criteria (1 listed)
- all patients who are candidate for transcatheter PDA closure.
Key exclusion criteria (8 listed)
- Patients with PDA dependent pulmonary circulation.
- Patients with small sized PDA which is silent by auscultation.
- Patients with large sized PDA which is unsuitable for Trans-catheter closure .
- Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
- Patients with active infection or active infective endarteritis.
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 |
|---|---|---|
| speckle tracking echocardiographybefore and after closure of the PDA , echocardiographic loops of the apical 4, 3 , and 2 chamber will be acquired then processed by special software for measuring the speckle movements in the longitudinal and short axis views | Other | Adults, children |
Primary outcome
change of LV strain after transcatheter closure of the PDA
Time frame: at base line, within 48 hours after closure of the duct then at three and six months
Assess the change of left ventricular longitudinal and circumferential strain by speckle tracking echocardiography after PDA closure, and compare this change between the children and adults.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Background: PubMed 27524443Morton SU, Brodsky D. Fetal Physiology and the Transition to Extrauterine Life. Clin Perinatol. 2016 Sep;43(3):395-407. doi: 10.1016/j.clp.2016.04.001. Epub 2016 Jun 11.
- Background: PubMed 18641675Weir EK, Obreztchikova M, Vargese A, Cabrera JA, Peterson DA, Hong Z. Mechanisms of oxygen sensing: a key to therapy of pulmonary hypertension and patent ductus arteriosus. Br J Pharmacol. 2008 Oct;155(3):300-7. doi: 10.1038/bjp.2008.291. Epub 2008 Jul 21.
- Background: PubMed 29716712P S, Jose J, George OK. Contemporary outcomes of percutaneous closure of patent ductus arteriosus in adolescents and adults. Indian Heart J. 2018 Mar-Apr;70(2):308-315. doi: 10.1016/j.ihj.2017.08.001. Epub 2017 Aug 9.
- Background: PubMed 22414886Schneider DJ. The patent ductus arteriosus in term infants, children, and adults. Semin Perinatol. 2012 Apr;36(2):146-53. doi: 10.1053/j.semperi.2011.09.025.
- Background: PubMed 21385887Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. Eur J Echocardiogr. 2011 Mar;12(3):167-205. doi: 10.1093/ejechocard/jer021.
- Background: PubMed 21193707Mondillo S, Galderisi M, Mele D, Cameli M, Lomoriello VS, Zaca V, Ballo P, D'Andrea A, Muraru D, Losi M, Agricola E, D'Errico A, Buralli S, Sciomer S, Nistri S, Badano L; Echocardiography Study Group Of The Italian Society Of Cardiology (Rome, Italy). Speckle-tracking echocardiography: a new technique for assessing myocardial function. J Ultrasound Med. 2011 Jan;30(1):71-83. doi: 10.7863/jum.2011.30.1.71.
- Background: PubMed 17084180Edvardsen T, Helle-Valle T, Smiseth OA. Systolic dysfunction in heart failure with normal ejection fraction: speckle-tracking echocardiography. Prog Cardiovasc Dis. 2006 Nov-Dec;49(3):207-14. doi: 10.1016/j.pcad.2006.08.008.
- Background: PubMed 25107547Amoogzar H, Shakiba AM, Derakhshan D, Ajami G, Cheriki S, Borzouee M, Edraki MR, Mehdizadegan N. Evaluation of left ventricular function by tissue Doppler and speckle-derived strain rate echocardiography after percutaneous ductus closure. Pediatr Cardiol. 2015 Jan;36(1):219-25. doi: 10.1007/s00246-014-0989-0. Epub 2014 Aug 9.
- Background: PubMed 23721219Tilahun B, Tefera E. Transient left ventricular systolic dysfunction following surgical closure of large patent ductus arteriosus among children and adolescents operated at the cardiac centre, Ethiopia. J Cardiothorac Surg. 2013 May 31;8:139. doi: 10.1186/1749-8090-8-139.
- Background: PubMed 17719286Jeong YH, Yun TJ, Song JM, Park JJ, Seo DM, Koh JK, Lee SW, Kim MJ, Kang DH, Song JK. Left ventricular remodeling and change of systolic function after closure of patent ductus arteriosus in adults: device and surgical closure. Am Heart J. 2007 Sep;154(3):436-40. doi: 10.1016/j.ahj.2007.04.045.
- Background: PubMed 32333933Zhan Z, Guan L, Pan W, Zhang X, Zhang L, Zhou D, Ge J. Left ventricular size and function after percutaneous closure of patent ductus arteriosus in Chinese adults. Int J Cardiol. 2020 Sep 15;315:24-28. doi: 10.1016/j.ijcard.2020.04.060. Epub 2020 Apr 22.
- Background: PubMed 32494943Yasuhara J, Kuno T, Kumamoto T, Kojima T, Shimizu H, Yoshiba S, Kobayashi T, Sumitomo N. Comparison of transcatheter patent ductus arteriosus closure between children and adults. Heart Vessels. 2020 Nov;35(11):1605-1613. doi: 10.1007/s00380-020-01639-4. Epub 2020 Jun 3.
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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 Congenital Heart Defect and Patent Ductus Arteriosus, run by Ahmed Mohamed Moheb El-Din.
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 8 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 16 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?
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?
change of LV strain after transcatheter closure of the PDA (time frame: at base line, within 48 hours after closure of the duct then at three and six months). 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 NCT04964531, which also lists 12 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 16 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.