Effects of stenting on exercise capacity in patients with certain congenital heart defects

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

This study is testing if a procedure to open blocked arteries can help people with certain heart defects, like d-TGA, ToF, and TA, exercise better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 8 Years and up
• Sex: All
• Sponsor: UMC Utrecht (other)
• Locations: 4 sites (Amsterdam and 3 other locations)
• Trial ID: NCT05809310 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the impact of percutaneous interventions for branch pulmonary artery stenosis on exercise capacity in patients with dextro transposition of the great arteries (d-TGA), Tetralogy of Fallot (ToF), and Truncus Arteriosus (TA). Participants will undergo a series of examinations, including echocardiograms and cardiopulmonary exercise testing, at baseline and approximately six months later. The study also seeks to assess right ventricular function and identify early markers for improving the timing of these interventions. It is a multicenter randomized controlled trial conducted across several Dutch interventional centers.

Who should consider this trial

Good fit: Ideal candidates include patients aged 8 years and older with d-TGA post arterial switch operation, ToF, or TA.

Not a fit: Patients with significant comorbidities or severe right ventricular dysfunction may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this study could enhance exercise capacity and overall quality of life for patients with specific congenital heart defects.

How similar studies have performed: While the effects of percutaneous interventions for branch PA stenosis are not well-established, similar approaches in other studies have shown promise in improving outcomes for patients with congenital heart defects.

Eligibility criteria

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)

Where this trial is running

Amsterdam and 3 other locations

• Amsterdam University Medical Center location AMC — Amsterdam, Netherlands (NOT_YET_RECRUITING)
• Leiden University Medical Center — Leiden, Netherlands (NOT_YET_RECRUITING)
• Erasmus Medical Center — Rotterdam, Netherlands (NOT_YET_RECRUITING)
• UMC Utrecht/WKZ — Utrecht, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Hans Breur, MD, PhD

Conditions: Transposition of Great Vessels, Tetralogy of Fallot, Truncus Arteriosus, Pulmonary Artery Stenosis Supravalvular Congenital, Stent Stenosis, Right Ventricular Dysfunction, Congenital Heart Disease, Exercise capacity