Early Right Ventricular Function After Repair Of Tetralogy Of Fallot , An Evidence Based Study.

NCT03470064 | Unknown

• 1 other identifier: 17200175
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to assessing right ventricular function early after surgical repair of tetralogy of Fallot and identifying the risk factors associated with development of RV dysfunction.

Conditions

Tetralogy of Fallot

Outcome Measures

Primary Outcomes (1)

• Assessment of RV function early after surgical repair of tetralogy of fallot

  the study aim to assess the function of the Right ventricle early after surgical repair of tetralogy of fallot by echocardiography.

  within one week postoperative

Secondary Outcomes (1)

• Follow up the course of RV function over a period of three months in patients of tetralogy of fallot following surgical repair .

  3 months postoperative

Study Arms (1)

RV Dysfunction

All pediatric patients who present to pediatric cardiothoracic unit, Assiut University Hospital and who meet the listed inclusion and exclusion criteria will be eligible for the study. Patients' charts will be retrieved based on their surgical procedures. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base for later data analysis

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

1. Pediatric patients up to 12 years old. 2. Recent echocardiography before the surgery giving detailed data about the components congenital anomalies of tetralogy of Fallot and if there are other associated congenital anomalies. 3. Obtaining written informed consent from parents or guardians of all patients confirming their willing and comply with study requirements 4. Parents or guardians of the Patient are willing to comply with all follow-up visits

You may qualify if:

• Pediatric patients up to 12 years old.
• Recent echocardiography before the surgery giving detailed data about the components congenital anomalies of tetralogy of Fallot and if there are other associated congenital anomalies.
• Obtaining written informed consent from parents or guardians of all patients confirming their willing and comply with study requirements
• Parents or guardians of the Patient are willing to comply with all follow-up visits.

You may not qualify if:

• Patients with tetralogy of Fallot who are indicated to palliative procedures and not for definitive surgical repair as in case of:-
• Neonates with TOF and pulmonary atresia
• Children with hypoplastic pulmonary artery
• Age less than 3 months who have medically unmanageable hypoxic spells
• Infant weight less than 2.5 kg
• Abnormal coronary artery anatomy
• Patients with TOF who are contraindicated to primary repair as in case of:-
• Multiple VSDs
• Multiple coexisting intracardiac malformations
• Small pulmonary arteries
• Very low birth weight
• The presence of an anomalous coronary artery
• Patient inaccessible for follow-up visits required by protocol.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut University

Asyut, 71515, Egypt

NOT YET RECRUITING

Assiut University

Asyut, Egypt

RECRUITING

Related Publications (10)

• Tamborini G, Muratori M, Brusoni D, Celeste F, Maffessanti F, Caiani EG, Alamanni F, Pepi M. Is right ventricular systolic function reduced after cardiac surgery? A two- and three-dimensional echocardiographic study. Eur J Echocardiogr. 2009 Jul;10(5):630-4. doi: 10.1093/ejechocard/jep015. Epub 2009 Feb 27.

  PMID: 19252190 BACKGROUND

• Eroglu AG, Sarioglu A, Sarioglu T. Right ventricular diastolic function after repair of tetralogy of Fallot: its relationship to the insertion of a 'transannular' patch. Cardiol Young. 1999 Jul;9(4):384-91.

  PMID: 10476828 BACKGROUND

• Higgins CB. Which standard has the gold? J Am Coll Cardiol. 1992 Jun;19(7):1608-9. doi: 10.1016/0735-1097(92)90626-x. No abstract available.

  PMID: 1534338 BACKGROUND

• Carminati M, Pluchinotta FR, Piazza L, Micheletti A, Negura D, Chessa M, Butera G, Arcidiacono C, Saracino A, Bussadori C. Echocardiographic assessment after surgical repair of tetralogy of fallot. Front Pediatr. 2015 Feb 2;3:3. doi: 10.3389/fped.2015.00003. eCollection 2015.

  PMID: 25699243 BACKGROUND

• Jategaonkar SR, Scholtz W, Butz T, Bogunovic N, Faber L, Horstkotte D. Two-dimensional strain and strain rate imaging of the right ventricle in adult patients before and after percutaneous closure of atrial septal defects. Eur J Echocardiogr. 2009 Jun;10(4):499-502. doi: 10.1093/ejechocard/jen315. Epub 2009 Jan 20.

  PMID: 19155264 BACKGROUND

• Frigiola A, Redington AN, Cullen S, Vogel M. Pulmonary regurgitation is an important determinant of right ventricular contractile dysfunction in patients with surgically repaired tetralogy of Fallot. Circulation. 2004 Sep 14;110(11 Suppl 1):II153-7. doi: 10.1161/01.CIR.0000138397.60956.c2.

  PMID: 15364855 BACKGROUND

• Eidem BW, O'Leary PW, Tei C, Seward JB. Usefulness of the myocardial performance index for assessing right ventricular function in congenital heart disease. Am J Cardiol. 2000 Sep 15;86(6):654-8. doi: 10.1016/s0002-9149(00)01047-x.

  PMID: 10980218 BACKGROUND

• Anavekar NS, Gerson D, Skali H, Kwong RY, Yucel EK, Solomon SD. Two-dimensional assessment of right ventricular function: an echocardiographic-MRI correlative study. Echocardiography. 2007 May;24(5):452-6. doi: 10.1111/j.1540-8175.2007.00424.x.

  PMID: 17456062 BACKGROUND

• Wheeler M, Leipsic J, Trinh P, Raju R, Alaamri S, Thompson CR, Moss R, Munt B, Kiess M, Grewal J. Right Ventricular Assessment in Adult Congenital Heart Disease Patients with Right Ventricle-to-Pulmonary Artery Conduits. J Am Soc Echocardiogr. 2015 May;28(5):522-32. doi: 10.1016/j.echo.2014.11.016. Epub 2015 Jan 30.

  PMID: 25648672 BACKGROUND

• Leonardi B, Taylor AM, Mansi T, Voigt I, Sermesant M, Pennec X, Ayache N, Boudjemline Y, Pongiglione G. Computational modelling of the right ventricle in repaired tetralogy of Fallot: can it provide insight into patient treatment? Eur Heart J Cardiovasc Imaging. 2013 Apr;14(4):381-6. doi: 10.1093/ehjci/jes239. Epub 2012 Nov 20.

  PMID: 23169758 BACKGROUND

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ehab Zahran, PHD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ehab Zahran, PHD

CONTACT

00201220589292; dr.ehabzahran@gmail.com

Zahran

CONTACT

ehabzahran098@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at cardiothoracic surgery department

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: March 19, 2018
• Study Start: April 1, 2018
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

EG (2)