StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation

Overview

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 several KTx centers. 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 (eGFR), pulse wave velocity (PWV) and intima media thickness (IMT) 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. 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.

Interventions

• Other Intensified BP control
  Treatment goal in the intensified group will be lowering BP ≤60th pct.
• Other Standard Treatment
  Standard treatment is to achieve BP levels \&lt;90th pct.

Primary outcome measures

• Left ventricular mass index (LVMI) [Time frame: At 24 months after randomization]

Secondary outcome measures (3)

• Pulse Wave velocity (PWV) [Time frame: At 24 months after randomization]
• Estimated Glomerular Filtration Rate (eGFR) [Time frame: At 24 months after randomization]
• Intima Media Thickness (IMT) [Time frame: At 24 months after randomization]

Eligibility criteria

Inclusion criteria

• Kidney transplantation \&gt;12 months ago
• Arterial hypertension

Exclusion criteria

• Cardiac malformation
• Treatment for a rejection episode within three months prior to inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Grabitz C, Memaran N, Sugianto RI, von der Born J, Bukova M, Lehmann E, Konuhov AK, Holzwart D, Grosshennig A, Wuhl E, Schmidt BMW, Melk A. StOPping Hypertension and imprOving Children's Lives after KidnEy TranSplantation (SOPHOCLES): study protocol for a randomized controlled multicenter trial. Trials. 2025 Aug 27;26(1):315. doi: 10.1186/s13063-025-09033-z. PMID 40866927

Identifiers

NCT: NCT06589947 · SOPHOCLES

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗