StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation

Not Applicable

Not yet recruiting

• Conditions: Arterial Hypertension; Kidney Transplant; Complications
• Interventions: Other: Standard Treatment; Other: Intensified BP control

• Registration Number: NCT06589947
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Study Start: 2024-09-16
• Primary Completion: 2028-09
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard BP group	Standard Treatment	The treatment goal for the standard group is to achieve BP levels \<90th pct.
Intensified BP group	Intensified BP control	Treatment goal in the intensified group will be lowering BP ≤60th pct.

Primary Outcome Measures

Name	Time	Method
Left ventricular mass index (LVMI)	At 24 months after randomization	LVMI at 24 months after randomization. Echocardiography will follow a standardized operating procedure established during the 4C study in accordance with the American Society of Echocardiography guidelines. LVMI will be calculated by dividing left-ventricular mass in grams (according to Devereux) by height in meters to the 2.16th with a correction factor of 0.09.

Secondary Outcome Measures

Name	Time	Method
Pulse Wave velocity (PWV)	At 24 months after randomization	PWV at 24 months after randomization.
Estimated Glomerular Filtration Rate (eGFR)	At 24 months after randomization	eGFR estimated by the Schwartz bedside formula at 24 months after randomization.
Intima Media Thickness (IMT)	At 24 months after randomization	IMT at 24 months after randomization. IMT will be assessed using ultrasound with a high-resolution linear probe, by averaging five measurements from the far wall of the common carotid artery 1-2 cm proximal of the carotid bulb, following the Mannheim consensus.