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

索福克勒斯（StOP 高血压：改善肾移植后儿童的生活）

• 批准号: 501533783
• 负责人: Professorin Dr. Anette Melk, Ph.D.
• 金额: --
• 依托单位: Klinik für pädiatrische Nieren-, Leber- und Stoffwechselerkrankungen
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/501533783?language=en
• 关键词: SOPHOCLES; StOP; Hypertension; imprOving; Children

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.

心血管(CV)疾病是儿童肾移植(KTX)后的主要发病率，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，在这一患者组中高度丰富。AH可导致左心室肥厚(LVH)，是心血管死亡的预测因素。测量左心室重量指数(LVMI)可以无创性地评价左心室肥厚。对观察数据的分析表明，血压(BP)水平和75%的百分位数(Pct)与LVMI的显著降低有关。指南为患有慢性肾脏疾病(CKD)的儿童制定了BP目标。然而，对于儿童KTX患者的急性肝炎的治疗，目前还没有指南。在拟议的多中心、随机、平行分组试验中，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KTX后12个月的n=500名儿科患者。患者将按1：1随机分配到强化血压管理组(BP目标=60%)和标准BP管理组(BP目标=90%)。24个月后的主要终点是LVMI。次要终点是24个月后估计的肾小球滤过率、脉搏波速度和内中膜厚度。两组的血压控制将通过BP远程监测得到保证，这些监测将实时传输到治疗医生和试验的中央BP办公室。在加强血压管理的情况下，试诊医生将每月与治疗医生讨论患者的血压水平，如果尚未达到血压目标，则与治疗医生讨论潜在的治疗方案。这将保证这两个群体之间的明确区别。通过定义适当的BP目标，拟议的研究结果将对KTX后儿童的护理产生直接影响。这一结果将明确KTX后护理的一个重要因素，并有助于降低儿童KTX患者的心血管发病率和随后的心血管死亡率。