Related Experiment Video
Updated: Sep 10, 2025
Improved Home Blood Pressure Control by CT-guided Ozone-mediated Renal Denervation for Patients with Resistant Hypertension
Published on: June 6, 2025
StOPping Hypertension and imprOving Children's Lives after KidnEy TranSplantation (SOPHOCLES): study protocol for a
Carl Grabitz1,2, Nima Memaran1,2,3, Rizky I Sugianto1,2
1Department of Pediatric Kidney, Liver, Metabolic and Neurological Diseases, Hannover Medical School, Hannover, Germany.
Insights
This study investigates if stricter blood pressure control in pediatric kidney transplant recipients can reduce left ventricular mass. Findings will inform evidence-based targets to lower cardiovascular risk in these children.
Area of Science:
- Pediatric Nephrology
- Cardiovascular Research
- Transplantation Medicine
Background:
- Cardiovascular disease is a significant complication in pediatric kidney transplant recipients, impacting life expectancy and graft function.
- Arterial hypertension is a primary risk factor, leading to left ventricular hypertrophy (LVH), a predictor of cardiovascular mortality.
- Current guidelines for pediatric transplant patients use targets for otherwise healthy children, potentially suboptimal for this high-risk group.
Purpose of the Study:
- To determine if intensified blood pressure management (≤60th percentile) reduces left ventricular mass compared to standard management (<90th percentile) in pediatric kidney transplant recipients.
- To establish evidence-based blood pressure targets for this population.
- To potentially decrease cardiovascular morbidity and mortality in pediatric kidney transplant recipients.
Main Methods:
- A multicenter, randomized trial with blinded endpoint evaluation involving 170 pediatric kidney transplant patients.
- Random assignment to either intensified (≤60th percentile) or standard (<90th percentile) blood pressure targets.
- Primary endpoint: left ventricular mass at 24 months. Secondary endpoints include pulse wave velocity, intima media thickness, eGFR, and albuminuria. Blood pressure telemonitoring will facilitate target achievement.
Main Results:
- This section is to be filled after the study's completion.
Conclusions:
- The study aims to provide evidence for defining optimal blood pressure targets in pediatric kidney transplant recipients.
- Effective intensified blood pressure targets could lead to reduced cardiovascular morbidity and mortality.
- Results will directly influence clinical care guidelines for this vulnerable patient population.
Background:
Cardiovascular 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.
Methods:
In 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 Registration:
ClinicalTrials.gov NCT06589947. Registered on September 6, 2024.
Related Concept Videos
01:28Kidney Transplant I: Introduction
01:26Kidney Transplant II: Surgical Procedure
01:30Hypertension III: Clinical Manifestations and Diagnostic Studies
01:16Kidney Transplant III: Nursing Management
01:28Hypertension IV: Drug Therapy and Lifestyle Modifications
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...