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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Netherlands
Amsterdam University Medical Center location AMC
NOT_YET_RECRUITING
Amsterdam
Leiden University Medical Center
NOT_YET_RECRUITING
Leiden
Erasmus Medical Center
NOT_YET_RECRUITING
Rotterdam
UMC Utrecht/WKZ
RECRUITING
Utrecht
Contact Information
Primary
Hans Breur, MD, PhD
h.breur@umcutrecht.nl
+31 88 75 754 59
Backup
Renée Joosen, MSc
r.s.joosen-2@umcutrecht.nl
Time Frame
Start Date: 2023-04-18
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 56
Treatments
Experimental: Interventional group
Percutaneous intervention for PA stenosis
No_intervention: Control group
Conservative management (percutaneous intervention for PA stenosis 6 months postponed)
Sponsors
Collaborators: Dutch Heart Foundation, Hartekind, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), Erasmus Medical Center, Leiden University Medical Center
Leads: UMC Utrecht

This content was sourced from clinicaltrials.gov