Actively Recruiting
Led by UMC Utrecht · Updated on 2025-03-30
56
Participants Needed
4
Research Sites
N/A
Total Duration
U
UMC Utrecht
Lead Sponsor
D
Dutch Heart Foundation
Collaborating Sponsor
Researchers are studying the effects of percutaneous interventions for branch pulmonary artery (PA) stenosis on exercise capacity in patients with dextro transposition of the great arteries (d-TGA), Tetralogy of Fallot (ToF), and Truncus Arteriosus (TA). This randomized controlled trial also aims to assess the impact of these interventions on right ventricular (RV) function and to identify early markers to improve the timing of treatment. The study responds to the need for clearer guidelines on when to perform these interventions, as current knowledge about their effects on exercise capacity and heart function is limited. Participants are divided into two groups: one undergoing percutaneous stent placement for PA stenosis and a control group receiving conservative management with potential delayed intervention. Both groups will receive standard care evaluations, including transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET), and cardiac magnetic resonance imaging (CMR). The interventional group will have additional low dose dobutamine stress MRI at certain centers and RV pressure measurements during the intervention. Quality of life questionnaires will be collected at baseline and shortly after intervention or corresponding time points in controls. Long-term follow-up with TTE, CPET, and CMR will occur within 2 to 4 years. During the study, participants will undergo examinations at baseline and approximately six months later to measure exercise capacity (VO2 max), RV function, and adaptation. Assessments include imaging, exercise testing, and questionnaires to evaluate heart performance and quality of life. Researchers will compare results between groups to determine the effects of the intervention. Safety and technical success will also be monitored through pressure and gradient measurements. The total study duration includes initial assessments, intervention or observation periods, and extended follow-up to understand long-term outcomes.
CONDITIONS
Effects Branch PA Stenting d-TGA, ToF and TA
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks prior to intervention
Participants undergo baseline examinations including transthoracic echocardiogram, cardiopulmonary exercise testing, and cardiac MRI. For the interventional group, the baseline MRI is performed as close as possible prior to the intervention but no more than 4 weeks before.
1 to 2 visits depending on group assignment
Duration - Single intervention visit with possible follow-up within 6 months
Participants in the interventional group receive percutaneous stenting for branch pulmonary artery stenosis. Those in the control group receive conservative management and may receive intervention after approximately 6 months if necessary.
1 intervention visit (in-person) and quality of life questionnaire 2 weeks after intervention or comparable time in control group
Duration - Approximately 6 months after baseline
Participants undergo follow-up examinations including echocardiogram, exercise testing, and cardiac MRI to assess effects of intervention or conservative management.
1 visit (in-person)
Duration - 2 to 4 years after baseline
Participants have additional assessments at 2 to 4 years to evaluate long-term effects on heart function and exercise capacity.
1 to 2 visits
Total: 4 locations
1
Amsterdam University Medical Center location AMC
Amsterdam, Netherlands, 1105 AZ
Not Yet Recruiting
2
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Not Yet Recruiting
3
Erasmus Medical Center
Rotterdam, Netherlands, 3015 CN
Not Yet Recruiting
4
UMC Utrecht/WKZ
Utrecht, Netherlands, 3584 CX
Actively Recruiting
H
Hans Breur, MD, PhD
R
Renée Joosen, MSc
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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R S Joosen, M Voskuil, T B Krasemann...
https://pubmed.ncbi.nlm.nih.gov/39227910