StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation

NCT06589947 | Not Yet Recruiting DMC

• 1 other identifier: SOPHOCLES
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arterial Hypertension; Kidney Transplant; Complications

Keywords

Left ventricular mass; Pediatric kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Left ventricular mass index (LVMI)

  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.

  At 24 months after randomization

Secondary Outcomes (3)

• Pulse Wave velocity (PWV)

  At 24 months after randomization

• Estimated Glomerular Filtration Rate (eGFR)

  At 24 months after randomization

• Intima Media Thickness (IMT)

  At 24 months after randomization

Other Outcomes (1)

• Albuminuria

  At 24 months after randomization

Study Arms (2)

Standard BP group

ACTIVE COMPARATOR

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

Other: Standard Treatment

Intensified BP group

EXPERIMENTAL

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

Other: Intensified BP control

Interventions

Intensified BP control OTHER

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

Intensified BP group

Standard Treatment OTHER

Standard treatment is to achieve BP levels \&lt;90th pct.

Standard BP group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Kidney transplantation \&gt;12 months ago
• Arterial hypertension

You may not qualify if:

• Cardiac malformation

Sponsors & Collaborators

• Hannover Medical School: lead
• Heidelberg; University of Heidelberg: collaborator
• Berlin; Charité: collaborator
• Bonn; Kindernieren-zentrum Bonn: collaborator
• Essen; University Hospital Essen: collaborator
• Frankfurt; Clementine Kinderhospital: collaborator
• Hamburg; University Hospital Hamburg-Eppendorf: collaborator
• Stuttgart; Olgahospital: collaborator
• Hacettepe University: collaborator
• Vienna; University Hospital Vienna: collaborator

Related Publications (1)

• Grabitz C, Memaran N, Sugianto RI, von der Born J, Bukova M, Lehmann E, Konuhov AK, Holzwart D, Grosshennig A, Wuhl E, Schmidt BMW, Melk A. StOPping Hypertension and imprOving Children's Lives after KidnEy TranSplantation (SOPHOCLES): study protocol for a randomized controlled multicenter trial. Trials. 2025 Aug 27;26(1):315. doi: 10.1186/s13063-025-09033-z.

  PMID: 40866927 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anette Melk, MD PhD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anette Melk, MD PhD

CONTACT

+49 511 532 0; sophocles@mh-hannover.de

Bernhard MW Schmidt, MD MSc

CONTACT

+49 511 532 0; sophocles@mh-hannover.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09