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

• Applicant: Professorin Anette Melk, Ph.D.
• Subject Area: Pediatric and Adolescent Medicine
• Term: since 2024
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 501533783

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.

• DFG Programme: Clinical Trials
• Major Instrumentation: Echokardiografie-Gerät
• Instrumentation Group: 3420 Elektrokardiographen
• Co-Investigators: Dr. Nima Memaran; Professor Dr. Bernhard Schmidt; Professorin Dr. Elke Wühl