Repaired Tetralogy of Fallot Italian Registry

Cardiac Arrhythmia Clinical Trial

— RETE-Fallot  

Official title:

Multicenter Italian Registry From the Italian Pediatric Cardiology Society (SICP) Working Group (WG) on CMR/CT for the Repaired Tetralogy of Fallot

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05288894
• Other study ID #: SICP WG CMR/CT 001
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: March 2027

Study information

• Verified date: April 2024
• Source: Azienda Ospedaliero, Universitaria Ospedali Riuniti
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The CMR/CT WG of the Italian pediatric cardiology society set up a multi-center observational clinical database of repaired-TOF evaluated. This registry will enroll prospectively patients evaluated by CMR for clinical indication in most of the CHD Italian centers. Data collection will include surgical history, clinical data, imaging data, and also adverse cardiac events for a period of 6 years.

Description:

This is an observational prospective registry that will enroll patients presenting with repaired Tetralogy of Fallot (TOF) undergoing a cardiac magnetic resonance (CMR) imaging study in our recruiting CMR-Laboratories.

CMR imaging studies will include the evaluation of biventricular volumes and function, atrial volumes and function, and the Late Gadolinium Enhancement (LGE), along with the evaluation of the anatomy and flow of the main pulmonary arteries and branches. We will also assess the aortic valve for regurgitation and measurement of the aortic size.

At follow-up, any interventional or surgical procedures performed and symptoms or any major (Death) and cardiac (cardiac-related hospitalization) events will be collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Patients with Repaired - TOF

Exclusion Criteria:

• Age < 10 years

• Other associated complex pathology such as MAPCAs, Atrioventricular canal, Ebstein

• Incomplete CMR exam

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Cardiac Death, Sudden
• Cardiac Event
• Cardiovascular Diseases
• Death
• Death, Sudden
• Death, Sudden, Cardiac
• Tetralogy of Fallot

Intervention

Diagnostic Test:
• Cardiac magnetic resonance imaging
A routine cardiac magnetic resonance imaging with biventricular function evaluation, atrial volumes, LGE acquisitions, and pulmonary and aortic assesment.

Locations

Country	Name	City	State
Italy	CCPC	Ancona	Marche

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Ospedali Riuniti	Fondazione Toscana Gabriele Monasterio, SICP WG CMR/CT

Country where clinical trial is conducted

Italy, 

References & Publications (21)

Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, Lung B, Kluin J, Lang IM, Meijboom F, Moons P, Mulder BJM, Oechslin E, Roos-Hesselink JW, Schwerzmann M, Sondergaard L, Zeppenfeld K; ESC Scientific Document Group. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021 Feb 11;42(6):563-645. doi: 10.1093/eurheartj/ehaa554. No abstract available. — View Citation

Berul CI, Hill SL, Geggel RL, Hijazi ZM, Marx GR, Rhodes J, Walsh KA, Fulton DR. Electrocardiographic markers of late sudden death risk in postoperative tetralogy of Fallot children. J Cardiovasc Electrophysiol. 1997 Dec;8(12):1349-56. doi: 10.1111/j.1540-8167.1997.tb01031.x. Erratum In: J Cardiovasc Electrophysiol 2000 Apr;11(4):ix. — View Citation

Bokma JP, Winter MM, Vehmeijer JT, Vliegen HW, van Dijk AP, van Melle JP, Meijboom FJ, Post MC, Zwinderman AH, Mulder BJ, Bouma BJ. QRS fragmentation is superior to QRS duration in predicting mortality in adults with tetralogy of Fallot. Heart. 2017 May;103(9):666-671. doi: 10.1136/heartjnl-2016-310068. Epub 2016 Nov 1. — View Citation

Clemente EA, Casares AP, Frontera PR, Calvar JMC, de Toledo JS. Finding the Optimal Timing for Repair of Standard Tetralogy of Fallot: Analysis of Cardiac Magnetic Resonance and Echocardiography Parameters Related to Intermediate Term Outcomes in a Pediatric Population. Pediatr Cardiol. 2021 Aug;42(6):1324-1333. doi: 10.1007/s00246-021-02615-z. Epub 2021 May 2. — View Citation

Diller GP, Dimopoulos K, Okonko D, Li W, Babu-Narayan SV, Broberg CS, Johansson B, Bouzas B, Mullen MJ, Poole-Wilson PA, Francis DP, Gatzoulis MA. Exercise intolerance in adult congenital heart disease: comparative severity, correlates, and prognostic implication. Circulation. 2005 Aug 9;112(6):828-35. doi: 10.1161/CIRCULATIONAHA.104.529800. Epub 2005 Aug 1. — View Citation

Egbe AC, Kothapalli S, Borlaug BA, Ammash NM, Najam M, Bajwa N, Tarek K, Mathew J, Connolly HM. Mechanism and Risk Factors for Death in Adults With Tetralogy of Fallot. Am J Cardiol. 2019 Sep 1;124(5):803-807. doi: 10.1016/j.amjcard.2019.05.048. Epub 2019 Jun 7. — View Citation

Festa P, Ait-Ali L, Prontera C, De Marchi D, Fontana M, Emdin M, Passino C. Amino-terminal fragment of pro-brain natriuretic hormone identifies functional impairment and right ventricular overload in operated tetralogy of Fallot patients. Pediatr Cardiol. 2007 Sep-Oct;28(5):339-45. doi: 10.1007/s00246-007-0009-8. Epub 2007 Jun 29. — View Citation

Geva T, Sandweiss BM, Gauvreau K, Lock JE, Powell AJ. Factors associated with impaired clinical status in long-term survivors of tetralogy of Fallot repair evaluated by magnetic resonance imaging. J Am Coll Cardiol. 2004 Mar 17;43(6):1068-74. doi: 10.1016/j.jacc.2003.10.045. — View Citation

Geva T. Indications for pulmonary valve replacement in repaired tetralogy of fallot: the quest continues. Circulation. 2013 Oct 22;128(17):1855-7. doi: 10.1161/CIRCULATIONAHA.113.005878. Epub 2013 Sep 24. No abstract available. — View Citation

Geva T. Repaired tetralogy of Fallot: the roles of cardiovascular magnetic resonance in evaluating pathophysiology and for pulmonary valve replacement decision support. J Cardiovasc Magn Reson. 2011 Jan 20;13(1):9. doi: 10.1186/1532-429X-13-9. — View Citation

Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. Report No.: 13(14)-EHC111. Available from http://www.ncbi.nlm.nih.gov/books/NBK208616/ — View Citation

Heng EL, Bolger AP, Kempny A, Davlouros PA, Davidson S, Swan L, Uebing A, Pennell DJ, Gatzoulis MA, Babu-Narayan SV. Neurohormonal activation and its relation to outcomes late after repair of tetralogy of Fallot. Heart. 2015 Mar;101(6):447-54. doi: 10.1136/heartjnl-2014-306398. Epub 2014 Oct 28. — View Citation

Hoffman JI. Incidence of congenital heart disease: I. Postnatal incidence. Pediatr Cardiol. 1995 May-Jun;16(3):103-13. doi: 10.1007/BF00801907. — View Citation

Ravaglioli A, Ait-Ali L, Federici D, Salvadori S, Pllumi A, Pak V, Marrone C, Pizzuto A, Bonhoeffer P, Festa P. The impact of native Fallot anatomy on future therapeutic requirements and outcomes at follow-up. Cardiovasc Ultrasound. 2021 Jun 19;19(1):23. doi: 10.1186/s12947-021-00249-y. — View Citation

Samad MD, Wehner GJ, Arbabshirani MR, Jing L, Powell AJ, Geva T, Haggerty CM, Fornwalt BK. Predicting deterioration of ventricular function in patients with repaired tetralogy of Fallot using machine learning. Eur Heart J Cardiovasc Imaging. 2018 Jul 1;19(7):730-738. doi: 10.1093/ehjci/jey003. — View Citation

Stout KK, Daniels CJ, Aboulhosn JA, Bozkurt B, Broberg CS, Colman JM, Crumb SR, Dearani JA, Fuller S, Gurvitz M, Khairy P, Landzberg MJ, Saidi A, Valente AM, Van Hare GF. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Apr 2;73(12):e81-e192. doi: 10.1016/j.jacc.2018.08.1029. Epub 2018 Aug 16. No abstract available. Erratum In: J Am Coll Cardiol. 2019 May 14;73(18):2361-2362. — View Citation

Toyono M, Harada K, Tamura M, Yamamoto F, Takada G. Myocardial acceleration during isovolumic contraction as a new index of right ventricular contractile function and its relation to pulmonary regurgitation in patients after repair of tetralogy of Fallot. J Am Soc Echocardiogr. 2004 Apr;17(4):332-7. doi: 10.1016/j.echo.2003.12.022. — View Citation

Trojano M. Can databasing optimise patient care? J Neurol. 2004 Sep;251 Suppl 5:v79-v82. doi: 10.1007/s00415-004-1513-x. — View Citation

Valente AM, Cook S, Festa P, Ko HH, Krishnamurthy R, Taylor AM, Warnes CA, Kreutzer J, Geva T. Multimodality imaging guidelines for patients with repaired tetralogy of fallot: a report from the AmericanSsociety of Echocardiography: developed in collaboration with the Society for Cardiovascular Magnetic Resonance and the Society for Pediatric Radiology. J Am Soc Echocardiogr. 2014 Feb;27(2):111-41. doi: 10.1016/j.echo.2013.11.009. No abstract available. — View Citation

Villafane J, Feinstein JA, Jenkins KJ, Vincent RN, Walsh EP, Dubin AM, Geva T, Towbin JA, Cohen MS, Fraser C, Dearani J, Rosenthal D, Kaufman B, Graham TP Jr; Adult Congenital and Pediatric Cardiology Section, American College of Cardiology. Hot topics in tetralogy of Fallot. J Am Coll Cardiol. 2013 Dec 10;62(23):2155-66. doi: 10.1016/j.jacc.2013.07.100. Epub 2013 Sep 27. — View Citation

Wald RM, Valente AM, Gauvreau K, Babu-Narayan SV, Assenza GE, Schreier J, Gatzoulis MA, Kilner PJ, Koyak Z, Mulder B, Powell AJ, Geva T. Cardiac magnetic resonance markers of progressive RV dilation and dysfunction after tetralogy of Fallot repair. Heart. 2015 Nov;101(21):1724-30. doi: 10.1136/heartjnl-2015-308014. Epub 2015 Aug 14. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac death	Number of Participants with cardiac-releted death	6 years
Secondary	Hospitalizations	Rate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure	6 years