Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD

July 22, 2025 updated by: Guy's and St Thomas' NHS Foundation Trust

Role of Three-dimensional Echocardiography Knowledge-based Reconstruction in Monitoring Right Ventricle Remodelling Following Tetralogy of Fallot Repair

The main objective of this study is to evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair.

As part of the validation study, the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers. Additionally, TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice, such as tricuspid annular plane systolic excursion (TAPSE), tissue Doppler imaging (TDI), fractional area change (FAC), and global longitudinal strain (GLS).

Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements, particularly with GLS.

The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition. The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tetralogy of Fallot (ToF) is a complex pathophysiology characterised by different factors that affect the right ventricle (RV) performance. Before surgical repair in childhood, the RV is exposed to pressure load with associated abnormal RV outflow tract (RVOT) hypertrophy and myocardial damage related to prolonged cyanosis. After surgical repair involving a pulmonary valve (PV) transannular patch, the RV may experience chronic volume overload due to significant pulmonary regurgitation (PR). The effects of chronic volume overload often found in adult congenital heart disease (ACHD) patients frequently result in progressive RV dilatation with abnormal geometry and RV dysfunction with associated electromechanical dyssynchrony. All this often leads to re-intervention with PV replacement. In asymptomatic patients with severe PR, the 2020 European ACHD guidelines recommendation for PV replacement gives a class 2a recommendation and evidence level C in cases of progressive RV systolic dysfunction and/or dilatation with a RV indexed end-diastolic volume (EDVi) ≥160 mL/m2, and/or a RV indexed end-systolic volume (ESVi) ≥80 mL/m2. The guidelines also mentioned gaps regarding the need for more longitudinal imaging data to optimise time for re-intervention because the possibility for RV remodelling is, at some point, irreversible.

CMR is widely recognised in the literature as the reference standard imaging technique for accurately quantifying RV volume and ejection fraction (EF) in the ACHD population. However, unlike transthoracic echocardiography (TTE), CMR is not the first-line test used in daily clinical practice.

The echocardiographic requirement of conventional multiple non-geometric (tricuspid annular plane systolic excursion, tissue Doppler imaging, global longitudinal strain) and geometric two-dimensional (2D) parameters (fractional area change, three-dimensional volume and EF) for a more accurate RV size and systolic function assessment is consensual in the literature with global longitudinal strain (GLS) emerging as a simple and effective tool for the management of repaired ToF patients. Also, it is known that conventional three-dimensional (3D) echocardiography systematically underestimates RV volumes and overestimates EF. Therefore, CMR and conventional 3D echo should not be used interchangeably.

Alternatively, 3D knowledge-based reconstruction derived from 2D echocardiography (TTE-3DKBR) has shown to be a valuable tool for RV volume and EF assessment that can complement CMR and maximise the available resources in clinical practice. The literature on TTE-3DKBR in children and adults with ToF indicates a high correlation with CMR, and its potential for clinical follow-up in repaired ToF patients may be relevant. However, the recommendations of the expert consensus documents are also clear that further validation studies are needed before its implementation in clinical practice.

The current longitudinal study aims to further the role of TTE-3DKBR in evaluating the effects of chronic RV volume overload in ACHD repaired ToF patients by assessing its reproducibility and accuracy against CMR and conventional echocardiography measurements, particularly with standard GLS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Group 1 of healthy adult volunteers

Group 2 of ACHD patients with repaired Tetralogy of Fallot and known moderate or severe pulmonary regurgitation

Description

Inclusion Criteria:

Group 1 of healthy adult volunteers - Minimum aged of 18 years old without evidence of structural heart disease.

Group 2 of ACHD patients - ACHD patient minimum aged of 18 years old with diagnosis of moderate or severe pulmonary regurgitation after ToF repair.

Exclusion Criteria:

Group 1 of healthy adult volunteers - No informed consent, evidence of structural heart disease.

Group 2 of ACHD patients - No informed consent, pacemaker or defibrillator non-compatible with CMR, limited echocardiographic images for image acquisition, and evidence of moderate or severe right ventricle inflow and/or right ventricle outflow tract obstruction.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
Healthy adult volunteers
Diagnostic test: Echocardiography assessment

Group 1 will have healthy adult volunteers recruited at the workplace following specific criteria to participate in the study. A research cardiac ultrasound protocol to assess the RV will be performed at two different visits, with a maximum interval of two weeks between them.

Group 2 will have ACHD patients with known moderate or severe pulmonary regurgitation after ToF repair, following specific criteria to participate in the study. This group of patients will be studied in two separate visits. The patients will be recruited during the first visit when attending to an existing hospital appointment for ACHD CMR. A research cardiac ultrasound protocol to assess the RV will be performed on the same day, either before or after the CMR. For all patients who will have a second follow-up visit at the ACHD outpatient clinic within a maximum interval of one year, the same research protocol will be performed, in addition to the usual cardiac ultrasound.

Other Names:
  • Cardiac Magnetic Resonance
Group 2
ACHD patients with repaired Tetralogy of Fallot and known moderate or severe pulmonary regurgitation
Diagnostic test: Echocardiography assessment

Group 1 will have healthy adult volunteers recruited at the workplace following specific criteria to participate in the study. A research cardiac ultrasound protocol to assess the RV will be performed at two different visits, with a maximum interval of two weeks between them.

Group 2 will have ACHD patients with known moderate or severe pulmonary regurgitation after ToF repair, following specific criteria to participate in the study. This group of patients will be studied in two separate visits. The patients will be recruited during the first visit when attending to an existing hospital appointment for ACHD CMR. A research cardiac ultrasound protocol to assess the RV will be performed on the same day, either before or after the CMR. For all patients who will have a second follow-up visit at the ACHD outpatient clinic within a maximum interval of one year, the same research protocol will be performed, in addition to the usual cardiac ultrasound.

Other Names:
  • Cardiac Magnetic Resonance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair.
Time Frame: First year of the study
To study what is the maximum considered acceptable mean difference between RV volumes measures between CMR and TTE-3DKBR.
First year of the study
Evaluate the effects of chronic RV volume overload in this population within one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurement of GLS.
Time Frame: Second year of the study
To study the predictive value of RV volumes using TTE-3DKBR to assess RV systolic dysfunction defined by GLS below -18%.
Second year of the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare TTE-3DKBR evaluation to the conventional 2D echocardiography measurements used in routine clinical practice (TAPSE, TDI, FAC, and GLS).
Time Frame: First year of the study
To study whether TTE-3DKBR values correlate with conventional 2D echocardiography measurements used in routine clinical practice (TAPSE, TDI, FAC and GLS).
First year of the study

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guy's and St Thomas' NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Manchester Metropolitan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dario Luis Leal de Freitas, BSc, Guy's and St Thomas' NHS Foundation Trust

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 324811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

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