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| Name | Class |
|---|---|
| Heidelberg University | OTHER |
| Berlin; Charité | UNKNOWN |
| Bonn; Kindernieren-zentrum Bonn | UNKNOWN |
| University Hospital, Essen |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard BP group | Active Comparator | The treatment goal for the standard group is to achieve BP levels <90th pct. |
|
| Intensified BP group | Experimental | Treatment goal in the intensified group will be lowering BP ≤60th pct. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensified BP control | Other | Treatment goal in the intensified group will be lowering BP ≤60th pct. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Wave velocity (PWV) | PWV at 24 months after randomization. | At 24 months after randomization |
| Estimated Glomerular Filtration Rate (eGFR) | eGFR estimated by the Schwartz bedside formula at 24 months after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Albuminuria | Albuminuria at 24 months after randomization. Albumine to creatinine ratio from spot urine will be assessed. | At 24 months after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anette Melk, MD PhD | Contact | +49 511 532 0 | 5597 | sophocles@mh-hannover.de |
| Bernhard MW Schmidt, MD MSc | Contact | +49 511 532 0 | 2329 | sophocles@mh-hannover.de |
| Name | Affiliation | Role |
|---|---|---|
| Anette Melk, MD PhD | Hannover Medical School | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40866927 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2024 | Sep 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Frankfurt; Clementine Kinderhospital | UNKNOWN |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| Stuttgart; Olgahospital | UNKNOWN |
| Hacettepe University | OTHER |
| Vienna; University Hospital Vienna | UNKNOWN |
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| Standard Treatment | Other | Standard treatment is to achieve BP levels <90th pct. |
|
| At 24 months after randomization |
| Intima Media Thickness (IMT) | 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. | At 24 months after randomization |