StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation

Summary

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.

Conditions

• Arterial Hypertension
• Kidney Transplant; Complications

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.

Sponsors & Collaborators

• Heidelberg; University of Heidelberg

  collaborator UNKNOWN

• Berlin; Charité

  collaborator UNKNOWN

• Bonn; Kindernieren-zentrum Bonn

  collaborator UNKNOWN

• Essen; University Hospital Essen

  collaborator UNKNOWN

• Frankfurt; Clementine Kinderhospital

  collaborator UNKNOWN

• Hamburg; University Hospital Hamburg-Eppendorf

  collaborator UNKNOWN

• Stuttgart; Olgahospital

  collaborator UNKNOWN

• Ankara; Hacettepe University Hospital

  collaborator UNKNOWN

• Vienna; University Hospital Vienna

  collaborator UNKNOWN

• Hannover Medical School

  lead OTHER

Principal Investigators

• Anette Melk, MD PhD · Hannover Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-16

Primary Completion

2028-09-30

Completion

2029-03-31