背景:分支肺动脉(PA)狭窄是大动脉转位(TGA)患者经皮介入治疗的最常见适应症之一,法洛四联症(ToF),和动脉干(TA)。然而,经皮分支PA干预对运动能力的影响在很大程度上仍然未知.此外,根据国际指南,对于无症状患者的最佳干预时机尚无共识.这项试验旨在确定经皮介入治疗分支PA狭窄对TGA患者运动能力的影响。ToF,还有TA。此外,它旨在评估对RV功能的影响,并确定RV适应和RV功能障碍的早期标志物,以改善这些干预措施的时机.
方法:这是一项随机多中心介入试验。TGA,ToF,根据国际指南,≥8岁且具有IIa级经皮分支PA干预指征的TA患者有资格参加。患者将被随机分为干预组或对照组(保守管理6个月)。所有患者都将接受经胸超声心动图检查,心脏磁共振成像,和基线时的心肺运动测试,6个月,和2-4年的随访。将在基线时获得生活质量(QoL)问卷,干预后2周或对照组相似范围,6个月的随访。主要结果是运动能力,表示为最大摄氧量(峰值VO2占预测百分比)。与对照组相比,总共56例患者(干预组n=28,对照组n=28)需要证明干预组的最大摄氧量(峰值VO2占预测百分比)增加了14%(功率80%,总体1型误差控制在5%)。次要结果包括右心室收缩功能的各种参数,RV功能,房车改造,程序上的成功,并发症,肺灌注,和QoL。
结论:该试验将研究经皮分支PA干预对TGA患者运动能力的影响,ToF,和TA,并将确定RV适应和RV功能障碍的早期标志物,以改善干预时机。
背景:ClinicalTrials.govNCT05809310。2023年3月15日注册。
BACKGROUND: Branch pulmonary artery (PA) stenosis is one of the most common indications for percutaneous interventions in patients with transposition of the great arteries (TGA), tetralogy of Fallot (ToF), and truncus arteriosus (TA). However, the effects of percutaneous branch PA interventions on exercise capacity remains largely unknown. In addition, there is no consensus about the optimal timing of the intervention for asymptomatic patients according to international guidelines. This trial aims to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with TGA, ToF, and TA. In addition, it aims to assess the effects on RV function and to define early markers for RV adaptation and RV dysfunction to improve timing of these interventions.
METHODS: This is a randomized multicenter interventional trial. TGA, ToF, and TA patients ≥ 8 years with a class IIa indication for percutaneous branch PA intervention according to international guidelines are eligible to participate. Patients will be randomized into the intervention group or the control group (conservative management for 6 months). All patients will undergo transthoracic echocardiography, cardiac magnetic resonance (CMR) imaging, and cardiopulmonary exercise testing at baseline, 6 months, and 2-4 years follow-up. Quality of life (QoL) questionnaires will be obtained at baseline, 2 weeks post intervention or a similar range for the control group, and 6 months follow-up. The primary outcome is exercise capacity expressed as maximum oxygen uptake (peak VO2 as percentage of predicted). A total of 56 patients (intervention group n = 28, control group n = 28) is required to demonstrate a 14% increase in maximum oxygen uptake (peak VO2 as percentage of predicted) in the interventional group compared to the control group (power 80%, overall type 1 error controlled at 5%). Secondary outcomes include various parameters for RV systolic function, RV functionality, RV remodeling, procedural success, complications, lung perfusion, and QoL.
CONCLUSIONS: This trial will investigate the effects of percutaneous branch PA interventions on exercise capacity in patients with TGA, ToF, and TA and will identify early markers for RV adaptation and RV dysfunction to improve timing of the interventions.
BACKGROUND: ClinicalTrials.gov NCT05809310. Registered on March 15, 2023.