StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation (SOPHOCLES)

Hannover Medical School (MHH)

Status: Not yet enrolling

Conditions: Arterial Hypertension; Kidney Transplant; Complications

Treatments: Other: Standard Treatment; Other: Intensified BP control

Study type: Interventional

Funder types: Other

Identifiers

NCT06589947

SOPHOCLES

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Standard BP group

Active Comparator group

Description:

The treatment goal for the standard group is to achieve BP levels \<90th pct.

Treatment:

Other: Standard Treatment

Intensified BP group

Experimental group

Description:

Treatment goal in the intensified group will be lowering BP ≤60th pct.

Treatment:

Other: Intensified BP control