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Tetralogy of FallotRETE-FallotNCT05288894

Repaired Tetralogy of Fallot Italian Registry

An observational study of Tetralogy of Fallot and Cardiac Death, Sudden, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 10 years and olderHealthy volunteers can take part
What is being tested?
Cardiac magnetic resonance imaging
How many people
150 participants
Where
1 siteItaly
Study dates
1 Mar 2021to Mar 2027
How long will I take part?
6 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 10 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Patients with a repaired-TOF without associated complex pathology underwent CMR imaging.

Who may be able to join

  • Patients with Repaired - TOF

Who cannot join

  • Age < 10 years
  • Other associated complex pathology such as MAPCAs, Atrioventricular canal, Ebstein
  • Incomplete CMR exam

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting

  • CCPC

    Ancona, The Marches, 60123

    Francesco Bianco, M.D., +39 071 596 5316, francesco.bianco@ospedaliriuniti.marche.it

    Recruiting

Other trials in Italy

About this study

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

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.

Read the detailed 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.

Being tested
Cardiac magnetic resonance imaging
Medical subject headings
Tetralogy of Fallot, Death, Sudden, Cardiac, Arrhythmias, Cardiac, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac magnetic resonance imagingDiagnostic test

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

Study groups in NCT05288894
Study groupRoleWhat they receive
Repaired Tetralogy of FallotA patient affected by Tetralogy of Fallot (right ventricle outflow obstruction, right ventricle hypertrophy, ventricular septal defect, aortic overriding of the ventricular defect) that already underwent cardiac surgery for the correction.
Receives: Diagnostic Test: Cardiac magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac death

    Number of Participants with cardiac-releted death

    Measured: 6 years

Secondary outcomes (1)

  1. Hospitalizations

    Rate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2022
  2. Study start1 Mar 2021
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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
150 participants (estimated)
Target duration
6 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05288894
Sponsor's protocol ID
SICP WG CMR/CT 001
Acronym
RETE-Fallot
Status last verified
Apr 2024
First submitted
11 Mar 2022
Last updated
16 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 7617503

  • 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.

    PubMed 24076489

  • 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.

    PubMed 21251297

  • 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.

    PubMed 24065609

  • 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.

    PubMed 15028368

  • 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.

    PubMed 29538684

  • 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.

    PubMed 26276804

  • 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/

    PubMed 24945055

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

    PubMed 15549361

  • 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.

    PubMed 34147117

  • 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.

    PubMed 33934202

  • 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.

    PubMed 31272701

  • 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.

    PubMed 27803032

  • 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.

    PubMed 9436772

  • 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.

    PubMed 24468055

Questions about this trial

What is this clinical trial studying?

An observational study of Tetralogy of Fallot and Cardiac Death, Sudden, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 1 site in Italy.

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 3 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: looking for participants now, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac death (time frame: 6 years). 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 NCT05288894, which also lists 21 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 Apr 2024.

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