Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
56 participants
INTERVENTIONAL
2023-04-18
2027-12-31
Brief Summary
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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)
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional group
Percutaneous intervention for PA stenosis
Percutaneous intervention (stent) for PA stenosis
Percutaneous intervention (stent placement) in one or both of the branch pulmonary arteries
Control group
Conservative management (percutaneous intervention for PA stenosis 6 months postponed)
No interventions assigned to this group
Interventions
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Percutaneous intervention (stent) for PA stenosis
Percutaneous intervention (stent placement) in one or both of the branch pulmonary arteries
Eligibility Criteria
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Inclusion Criteria
* Patients with d-TGA post ASO, ToF or TA
* ≥8 years
* 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)
8 Years
ALL
No
Sponsors
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Dutch Heart Foundation
OTHER
Hartekind
UNKNOWN
Erasmus Medical Center
OTHER
Leiden University Medical Center
OTHER
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
OTHER
UMC Utrecht
OTHER
Responsible Party
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Hans Breur
Dr.
Locations
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Amsterdam University Medical Center location AMC
Amsterdam, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
UMC Utrecht/WKZ
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Joosen RS, Voskuil M, Krasemann TB, Blom NA, Krings GJ, Breur JMPJ; Outreach consortium. The effects of percutaneous branch pulmonary artery interventions in biventricular congenital heart disease: study protocol for a randomized controlled Dutch multicenter interventional trial. Trials. 2024 Sep 3;25(1):581. doi: 10.1186/s13063-024-08436-8.
Other Identifiers
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NL81160
Identifier Type: -
Identifier Source: org_study_id
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