- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07568002
Impact of Transcatheter Patent Ductus Arteriosus Closure on Left Atrial and Ventricular Remodeling in Adults and Adolescents.
During the fetal life, small portion of the RV output passes to the lung through the pulmonary artery, while the greater portion is shunted to the descending aorta through the fetal ductus arteriosus (1) which is a connection between the left pulmonary artery and descending thoracic aorta just distal to the left subclavian artery.
With transition from intrauterine to extrauterine life, physiological changes occur resulting in left to right reversal of the shunt through the ductus arteriosus. Increased oxygenation after birth results in calcium and potassium channel activity ending in ductus closure(2).
Patent ductus arteriosus (PDA ) is a congenital heart disease(CHD) represents 6-11% of all CHDs (3) and results from failure of closure of the ductus beyond the third month of age(4).
However, there are a subset of patients who survive to adulthood undiagnosed, and it is present in adulthood with various clinical presentations. The clinical presentation, hemodynamics, and management of PDA presentation in adults depend on various factors, primarily the size of PDA, magnitude of shunting, and status of pulmonary vasculature (5).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
During the fetal life, small portion of the RV output passes to the lung through the pulmonary artery, while the greater portion is shunted to the descending aorta through the fetal ductus arteriosus (1) which is a connection between the left pulmonary artery and descending thoracic aorta just distal to the left subclavian artery.
With transition from intrauterine to extrauterine life, physiological changes occur resulting in left to right reversal of the shunt through the ductus arteriosus. Increased oxygenation after birth results in calcium and potassium channel activity ending in ductus closure(2).
Patent ductus arteriosus (PDA ) is a congenital heart disease(CHD) represents 6-11% of all CHDs (3) and results from failure of closure of the ductus beyond the third month of age(4).
However, there are a subset of patients who survive to adulthood undiagnosed, and it is present in adulthood with various clinical presentations. The clinical presentation, hemodynamics, and management of PDA presentation in adults depend on various factors, primarily the size of PDA, magnitude of shunting, and status of pulmonary vasculature (5).
According to the diameter, and length of the duct, the systemic and pulmonary vascular resistance, the duct may be hemodynamically insignificant or may result in pulmonary over circulation with subsequent left sided heart volume overload(5).
This volume overload induces left heart remodeling manifested by left atrial and ventricular dilatation and hypertrophy to compensate for the increased wall stress. Some patients can compensate well and remain asymptomatic, while others can't and develop heart failure and LV systolic dysfunction (6).
Traditional two dimensional (2D) and doppler echocardiography is the cornerstone tool for the diagnosis of PDA, evaluation of the magnitude and direction of its shunting, and measuring the pulmonary artery pressure(6). Speckle tracking echocardiography (STE) is a relatively novel application that helps in the assessment of the LV and RV function by tracking the speckles seen on the grey scale images of the traditional echocardiography (7). Recent studies showed good correlation between the global longitudinal strain (GLS) measured by the STE , left and Right ventricular ejection fraction (LVEF , RVEF ) measured by traditional 2D echocardiography (8). In addition, other studies revealed that STE could detect subtle myocardial dysfunction in heart failure patients with preserved LVEF (9).
Since the first surgical PDA closure by Gross and Hubbard in 1939 and the later transcatheter PDA closure by Portsmann et al. in 1967, there have been many significant developments in the devices used to close a PDA(10)(11) . In the past 20 years, transcatheter closure has become the leading approach to closure of most PDAs(12).
Complete closure rates at follow-up generally exceed 90- 95% in most studies. Serious complications of transcatheter closure of the PDA are rare.
In real world, cardiologists intervene adult patients with PDAs and have access to variable PDA closure coils and devices that can be implanted through different techniques and theoretically this should induce reverse LV remodeling with improvement of the Left heart dimensions and function (13). Fewer studies assessed the adults with PDA and their findings were late improvement of the LVEF after PDA closure (15,16,23)
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Emil Magdy Badry, Resident doctor
- Telefonnummer: +20 12 75470803
- E-mail: emilmagdy27@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- All adults and adolescent patients > 0r equal 12 yrs old who are candidate for trans-catheter PDA closure according to the latest European society of cardiology (ESC) and American Heart Associations (AHA) guidelines for management of patients with congenital heart diseases (CHD)(24).
Exclusion Criteria:
- 1. Patients with small sized PDA which is silent by auscultation. 2. Patients with large sized PDA which is unsuitable for Trans-catheter closure.
3. Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
4. Patients with active infection or active infective endocarditis. 5. Patients refuse to participate in the study. 6. Patients with diabetes, systemic hypertension and ischemic heart diseases. 7. Patients with associated congenital or acquired cardiac lesions that may affect/interfere with the LV mechanics.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
left atrial and ventricular Remodeling in Adults
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Transcatheter Patent Ductus Arteriosus Closure
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in myocardial strain parameters in lt atrium and ventricle before and after PDA ligation
Tidsramme: From enrollment to the end of treatment at 8 weeks
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From enrollment to the end of treatment at 8 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 1. Morton S, Brodsky D. Fetal Physiology and the Transition to Extrauterine Life. 2. Weir 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. Vol. 155, British Journal of Pharmacology. 2008. p. 300-7. 3. P S, Jose J, George OK. Contemporary outcomes of percutaneous closure of patent ductus arteriosus in adolescents and adults. Indian Heart J. 2018 Mar 1;70(2):308-15. 4. Forsey JT, Elmasry OA, Martin RP. Patent arterial duct. Orphanet J Rare Dis. 2009;4(1):1-9. 5. Schneider DJ, Moore JW. Patent Ductus Arteriosus. 2006 [cited 2021 Apr 4]; Available from: http://www.circulationaha.org 6. Schneider DJ. The Patent Ductus Arteriosus in Term Infants, Children, and A dults. Semin Perinatol [Internet]. 2012;36(2):146-53. Available from: http://dx.doi.org/10.1053/j.semperi.2011.09.025 7. Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux GG, et al. 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 [Internet]. 2011 Mar [cited 2017 Mar 25];12(3):167-205. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0894731711000484 8. Mondillo S, Galderisi M, Mele D, Cameli M, Lomoriello VS, Zacà V, et al. Speckle-tracking echocardiography: a new technique for assessing myocardial function. J Ultrasound Med [Internet]. 2011 Jan [cited 2018 Jul 14];30(1):71-83. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21193707 9. Edvardsen T, Helle-Valle T, Smiseth OA. Systolic Dysfunction in Heart Failure with Normal Ejection Fraction: Speckle-Tracking Echocardiography. Prog Cardiovasc Dis. 2006 Nov;49(3):207-14. 10. Gross RE, Hubbard JP. Surgical ligation of a patent ductus arteriosus: Report of first successful case. J Am Med Assoc. 1939 Feb 25;112(8):729-3
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Adult transcatheter PDA close
Plan for individuelle deltagerdata (IPD)
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