Clinical trial NCT06589947: StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation
Official title: StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arterial Hypertension
Kidney Transplant; Complications
Keywords: Left ventricular mass
Pediatric kidney transplantation
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Heidelberg; University of Heidelberg
name: Berlin; Charité
name: Bonn; Kindernieren-zentrum Bonn
name: Essen; University Hospital Essen
name: Frankfurt; Clementine Kinderhospital
name: Hamburg; University Hospital Hamburg-Eppendorf
name: Stuttgart; Olgahospital
name: Ankara; Hacettepe University Hospital
name: Vienna; University Hospital Vienna
First posted: 2024-09-19
Enrollment: 170
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Left ventricular mass index (LVMI)
timeFrame: At 24 months after randomization
Secondary outcomes:
measure: Pulse Wave velocity (PWV)
timeFrame: At 24 months after randomization
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: At 24 months after randomization
measure: Intima Media Thickness (IMT)
timeFrame: At 24 months after randomization
Other outcomes:
measure: Albuminuria
timeFrame: At 24 months after randomization
Locations:
Study officials:
affiliation: Hannover Medical School
name: Anette Melk, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: