ArticleTrials2025
StOPping Hypertension and imprOving Children's Lives after KidnEy TranSplantation (SOPHOCLES): study protocol for a randomized controlled multicenter trial.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06589947 (StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation), which is not on this map. Cited by 1 paper.
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StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation
Who cites it
1 citing paper in PubMed.
- Diastolic echocardiographic parameters identify pediatric kidney transplant recipients with structural myocardial alterations.Pediatric nephrology (Berlin, Germany) · 2026Article
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12 authors.
Funding
Abstract
backgroundCardiovascular disease is a major morbidity in children after kidney transplantation, limiting life expectancy and impairing graft function. Arterial hypertension is the dominant cardiovascular risk factor and highly abundant in this patient group. Arterial hypertension can cause left ventricular hypertrophy, which is predictive of cardiovascular death. Left ventricular hypertrophy can be non-invasively assessed by measuring left ventricular mass. Observational data indicated that intensified blood pressure control was associated with a significant reduction of left ventricular mass. Based on evidence from the randomized controlled ESCAPE trial, intensified blood pressure control is recommended in children with chronic kidney disease prior to kidney replacement therapy. However, current treatment recommendations for pediatric kidney transplant patients follow the recommendations for otherwise healthy children and adolescents with arterial hypertension, i.e., suggesting a blood pressure target < 90th percentile.
methodsIn the proposed multicenter, randomized, parallel group trial with blinded endpoint evaluation, we aim to include 170 pediatric patients who underwent a kidney transplantation more than 12 months ago. Patients will be randomly assigned 1:1 to an intensified blood pressure management group (blood pressure target ≤ 60th percentile) and a standard blood pressure management group (blood pressure target < 90th percentile). The primary endpoint is left ventricular mass after 24 months. Secondary endpoints are pulse wave velocity, intima media thickness, estimated glomerular filtration rate, and albuminuria. Achievement of blood pressure targets will be facilitated through blood pressure telemonitoring. Blood pressure values will be transmitted in real time to the treating physician and the trial's centralized study office allowing timely responses in case blood pressure values lie outside target range. DISCUSSION: The proposed study will result in an evidence-based definition of blood pressure targets and will therefore have direct implications for the care of children after kidney transplantation. In case intensified blood pressure targets are effective, this should eventually lead to lower cardiovascular morbidity and subsequently lower cardiovascular mortality of pediatric kidney transplant recipients.
trial registrationClinicalTrials.gov NCT06589947. Registered on September 6, 2024.
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