Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589947
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
StOPping Hypertension and imprOving Childrens Lives After KidnEy TranSplantation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
StOPping Hypertension and imprOving Childrens Lives After KidnEy TranSplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOPHOCLES
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 n500 pediatric patients 12 months after KTx at several KTx centers Patients will be randomly assigned 11 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 trials 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None