SOPHOCLES (StOP Hypertension: imprOving Children's Lives after KidnEy TranSplantation)

心血管（CV）疾病是肾移植（KTx）后儿童的主要发病率，限制了预期寿命并损害了移植物功能。动脉高血压（AH）是主要的心血管危险因素，在该患者组中非常丰富。AH可引起左心室肥厚（LVH），这是CV死亡的预测指标。LVH可以通过测量左心室质量指数（LVMI）进行无创评估。观察数据分析显示，血压（BP）水平<75百分位（pct）与LVMI显著降低相关。指南给出了儿童慢性肾脏疾病（CKD）的血压目标。然而，目前还没有关于小儿KTx患者AH治疗的指南。在拟议的多中心、随机、平行组试验中，我们的目标是在10个大型KTx中心（汉诺威、海德堡、柏林、波恩、埃森、法兰克福、汉堡、斯图加特、安卡拉、维也纳）评估n=500名KTx后12个月的儿童患者。患者将按1:1随机分配到强化血压管理组（血压目标<= 60%）和标准血压管理组（血压目标< 90%）。主要终点是24个月后LVMI。次要终点是24个月后估计的肾小球滤过率、脉搏波速度和内膜中膜厚度。两组患者的血压控制将通过血压远程监测得到保证，监测结果将实时传送给治疗医生和试验中心的血压办公室。在加强血压管理的情况下，试验医师将每月与治疗医师讨论患者的血压水平，如果没有达到血压目标，则讨论潜在的治疗方案。这将保证两组之间有明确的区别。通过确定适当的血压目标，提出的研究结果将对KTx后儿童的护理产生直接影响。该结果将确定KTx后护理的重要因素，并有助于降低儿科KTx患者的CV发病率和随后的CV死亡率。

Cardiovascular (CV) disease is a major morbidity in children after kidney transplantation (KTx), limiting life expectancy and impairing graft function. Arterial hypertension (AH) is the dominant CV risk factor, and highly abundant in this patient group. AH can cause left ventricular hypertrophy (LVH), which is predictive of CV death. LVH can be non-invasively assessed by measuring left ventricular mass index (LVMI). Analyses of observational data showed that blood pressure (BP) levels <75th percentile (pct) were associated with a significant reduction of LVMI. Guidelines give BP goals for children with chronic kidney disease (CKD). No guidelines, however, exist on the treatment of AH in pediatric KTx patients. In the proposed multicenter, randomized, parallel group trial with blinded endpoint evaluation we aim to assess n=500 pediatric patients >12 months after KTx at 10 large KTx centers (Hannover, Heidelberg, Berlin, Bonn, Essen, Frankfurt, Hamburg, Stuttgart, Ankara, Vienna). Patients will be randomly assigned 1:1 to an intensified BP management group (BP target <=60th pct) and a standard BP management group (BP target <90th pct). The primary endpoint is LVMI after 24 months. Secondary endpoints are estimated glomerular filtration rate, pulse wave velocity and intima media thickness after 24 months. BP control will be guaranteed for both groups through BP telemonitoring, which will be transmitted in real time to the treating physician and the trial’s centralized BP office. In case of intensified BP management, the trial physician will discuss patients’ BP levels and -in case BP targets have not been met- potential treatment options with the treating physician on a monthly basis. This will guarantee a clear distinction between the groups. By defining the adequate BP goal, the results of the proposed study will have direct implications for the care of children after KTx. The results will define an important element of post-KTx care and help to lower CV morbidity and subsequently CV mortality of pediatric KTx patients.