Effects Branch PA Stenting d-TGA, ToF and TA

March 25, 2025 updated by: Hans Breur, UMC Utrecht

The Effects of Branch Pulmonary Artery Stenting in d-TGA, ToF and TA: a Randomized Control Trial

The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA.

The main question[s] it aims to answer are:

The primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions.

Participants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht/WKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions.

Researchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale: Postoperative survival of patients with dextro transposition of the great arteries (d-TGA), Tetralogy of Fallot (ToF) and Truncus Arteriosus (TA) has increased over the last decades due to advances in operative techniques and perioperative care. Despite postoperative survival has increased, morbidity of these patients increases during long-term follow-up with a high need for reinterventions. Right ventricular outflow tract (RVOT) obstructions are the most common indication for a reintervention and percutaneous branch pulmonary artery (PA) interventions account for a significant number of these reinterventions. However, the effects of percutaneous branch PA interventions on exercise capacity, RV function and RV adaptation of patients with d-TGA, ToF and TA remains largely unknown. In addition, there is no consensus about the optimal timing for percutaneous interventions for branch PA stenosis in international guidelines.

Objective: The primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions.

Study design: This is a multicenter randomized controlled trial. Patients will be included from the following Dutch interventional centers for congenital heart disease: UMC Utrecht/WKZ (sponsor), LUMC/AUMC and Erasmus MC. During this trial there will be two groups: 1. a group of patients with d-TGA, ToF and TA who will undergo a percutaneous intervention for a branch PA stenosis according to standard care (intervention group) and 2. a group of patients with d-TGA, ToF and TA with a similar degree of pulmonary stenosis as group 1 (class IIa indication) who will undergo conservative management for a branch PA stenosis according to standard care (control group). If necessary, the control group will be able to undergo a percutaneous intervention for branch PA stenosis after the examinations at approximately 6 months follow-up, or sooner in case of symptoms. Patients from both groups will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht/WKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions.

Study population: d-TGA post ASO, ToF or TA patients ≥8 years old will be included if they have a class IIa indication for a percutaneous intervention for branch PA stenosis according to the international guidelines. Patients will be excluded if they contraindications for one of the examinations.

Main study parameters/endpoints: the difference in VO2 max (% predicted) as parameter for exercise capacity between the interventional and control group.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  • Patients with d-TGA post ASO, ToF or TA
  • ≥8 years

Exclusion Criteria:

One or more of the following inclusion criteria:

  • All class IIa indications for a branch PA intervention:

  • Persistent decreased RV function (based on gold standard CMR)

    • <18 years RVEF ≤55% (28)
    • ≥18 years RVEF<50% (29)
  • Progressive tricuspid regurgitation (TR) (≥moderate)

  • Isolated bifurcation stenosis:

    • Significant unilateral stenosis (≥50%)
    • Borderline bilateral PA stenosis (40-70%)
  • Unbalanced perfusion (≤35/65%)
  • RV/LV pressure ratio > 2/3 based on echocardiography

  • Reduced lung perfusion or decreased objective exercise capacity (based of gold standard VO2 max during CPET)

    • <18 years VO2 peak <35 mL∙kg-1∙min-1 (boys) VO2 peak <30 mL∙kg-1∙min-1 (girls) (30)
    • ≥18 years VO2 peak <27 mL∙kg-1∙min-1 (men) VO2 peak <19 mL∙kg-1∙min-1 (women) (31)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional group
Percutaneous intervention for PA stenosis
Procedure: Percutaneous intervention (stent) for PA stenosis
Percutaneous intervention (stent placement) in one or both of the branch pulmonary arteries
No Intervention: Control group
Conservative management (percutaneous intervention for PA stenosis 6 months postponed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline VO2max as percentage of predicted at 6 months as indication of exercise capacity
Time Frame: change between baseline and 6 months follow-up
using cardiopulmonary exercise test on a treadmill
change between baseline and 6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success using invasive right ventricular and pulmonary artery pressures and gradients
Time Frame: after the intervention, an average of 1 month after baseline
Technical success of the intervention using invasive right ventricular and pulmonary artery pressures and gradients
after the intervention, an average of 1 month after baseline
Peak workload (W)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using cardiopulmonary exercise test on a treadmill
at baseline, 6 months follow-up and 2-4 years follow-up
Peak workload (% predicted)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using cardiopulmonary exercise test on a treadmill
at baseline, 6 months follow-up and 2-4 years follow-up
O2 pulse (ml)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using cardiopulmonary exercise test on a treadmill
at baseline, 6 months follow-up and 2-4 years follow-up
O2 pulse (% predicted)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using cardiopulmonary exercise test on a treadmill
at baseline, 6 months follow-up and 2-4 years follow-up
VE/VCO2 slope
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using cardiopulmonary exercise test on a treadmill
at baseline, 6 months follow-up and 2-4 years follow-up
Right ventricular ejection fraction (%)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using CMR
at baseline, 6 months follow-up and 2-4 years follow-up
RV strain (%)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using speckle tracking echocardiography and CMR feature tracking
at baseline, 6 months follow-up and 2-4 years follow-up
RV fractional area change (%)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using echocardiography
at baseline, 6 months follow-up and 2-4 years follow-up
RV pressure (mmHg)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using echocardiography (TI gradient)
at baseline, 6 months follow-up and 2-4 years follow-up
RV end-systolic elastance
Time Frame: before and after the intervention, an average of 1 month after baseline
using pressure-volume analysis
before and after the intervention, an average of 1 month after baseline
RV end systolic volume (ml and ml/m2)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using CMR
at baseline, 6 months follow-up and 2-4 years follow-up
RV end diastolic volume (ml and ml/m2)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using CMR
at baseline, 6 months follow-up and 2-4 years follow-up
RV functional reserve
Time Frame: at baseline and 6 months follow-up in the interventional group from UMC Utrecht and Erasmus MC
RVEF dobutamine - RVEF rest using a low dose dobutamine stress MRI
at baseline and 6 months follow-up in the interventional group from UMC Utrecht and Erasmus MC
RV mass (g and g/m2)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using CMR
at baseline, 6 months follow-up and 2-4 years follow-up
Right ventricular pulmonary arterial (RV-PA) coupling
Time Frame: before and after the intervention, an average of 1 month after baseline
using pressure-volume analysis
before and after the intervention, an average of 1 month after baseline
Lung perfusion (%)
Time Frame: at baseline, 6 months follow-up and 2-4 years follow-up
using CMR
at baseline, 6 months follow-up and 2-4 years follow-up
Quality of Life (QoL) in 4 domains: health and related activities, emotional, social and school/work
Time Frame: at baseline and 2 weeks follow-up
using PedsQL questionnaire
at baseline and 2 weeks follow-up

Collaborators and Investigators

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

Sponsor

UMC Utrecht

Collaborators

Erasmus Medical Center
Leiden University Medical Center
Dutch Heart Foundation
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Hartekind

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 18, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL81160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will publish the results in peer-reviewed journals and present them at meetings and conferences. As the data is privacy-sensitive, the database will not be publically available. A request for a collaboration can be made via DataverseNL.

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.

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