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

July 19, 2022 updated by: ehab abd-alaal zahran, Assiut University
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The shape of the RV is dramatically modified by surgical repair of CHD, with infundibular bulging and apical dilation and deformation, leading to a large range of RV shapes(1,2). Moreover, pericardial section and suture during surgery influence RV geometry, as RV is normally more con-strained by the pericardium then the LV because of its thinner wall (3).

Intra cardiac repair(ICR) is the definitive management of TOF. Refinement in surgical techniques, advancements in anaesthetic & critical care has resulted in improving survival following ICR. Post operative mortality following ICR is reported between 1% - 5% (3). Post operative low cardiac output and mortality has been attributed to many factors such as anatomical defects with small main pulmonary artery annulus, severe hypoplasia or absent right or left pulmonary artery, ventriculotomy and right ventricular (RV) outflow patch, myocardial hypoxia during cardiopulmonary bypass, or ARDS (4). Certain patients despite satisfactory ICR exhibit difficult post operative course which is characterized by prolonged ventilation & inotropic support. These patients have been identified to exhibit features of RV dysfunction (low cardiac output, high central venous filling pressure, increased inotropic requirement, and prolonged ventilation). Identification of risk factors to characterise this subset of patients allows for better allocation of hospital resources, improved outcome, and substantially reduced hospital costs. This study will try to identify the risk factors associated with development of RV dysfunction & its course over a period of three months in patients of tetralogy following ICR.

MRI is a gold standard for assessment of right ventricular function (5). However, MRI has restricted availability, is costly, and there are many patients in whom MRI-non compatible devices prohibit its use.

Because of its complex shape, there is no geometrical assumption that can allow quantification of RV volumes and ejection fraction (RVEF) by standard two-dimensional (2D) echocardiography. For this reason, surrogate parameters of RV systolic function are used most frequently to assess RV systolic function, because they are easy to measure, feasible and reproducible. These parameters include:-

  • Tricuspid annulus movement:- Measurements of tricuspid annulus movement by M-mode (tricuspid annular plane systolic excursion [TAPSE]) or tissue Doppler imaging (peak systolic velocity [PSV]) are used most frequently to assess RV function; they are highly feasible and reproducible. However, several studies have shown their dependence on loading condition; TAPSE and PSV values are increased in volume overload and decreased in pressure overload (6), independent of RVEF.

-2D global longitudinal peak systolic strain of the RV lateral wall:- Speckle-tracking echocardiography is a new technology that allows quantification of myocardial regional deformation. The main advantage compared with tissue Doppler imaging is its angle independency; it was also thought to be less load dependent, but further studies demonstrated that 2D longitudinal strain values increase in volume overload and decrease in barometric overload (7).

- Isovolumic acceleration time(IVA):- Is a quantitative assessment of RV contractile function that is supposed to be unaffected by RV geometry or loading conditions. In patients with tetralogy of Fallot, studies have shown a good correlation between pulmonary regurgitation severity and IVA (8,9).

-Myocardial performance index :- Myocardial performance index (MPI) is another tissue Doppler-derived parameter of RV systolic function. MPI is calculated using the following formula: MPI =(isovolumic contraction time + isovolumic relaxation time)/ejection time (10).

- Fractional area change:- FAC has been shown to correlate well with RVEF measured by MRI in the general population (10).

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Asyut, Egypt, 71515
        • Not yet recruiting
        • Assiut University
        • Contact:
          • faculty of medicine faculty of medicine-assiut university
        • Contact:
      • Asyūţ, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  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.

Exclusion Criteria:

  1. 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

  2. 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
  3. Patient inaccessible for follow-up visits required by protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of RV function early after surgical repair of tetralogy of fallot
Time Frame: within one week postoperative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow up the course of RV function over a period of three months in patients of tetralogy of fallot following surgical repair .
Time Frame: 3 months postoperative
the study aim to follow up the function of the Right ventricle after surgical repair of tetralogy of fallot by echocardiography
3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ehab Zahran, PHD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

March 3, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17200175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tetralogy of Fallot

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe