An interventional study of Intensified BP control and Standard Treatment in Arterial Hypertension and Kidney Transplant; Complications, sponsored by Hannover Medical School. Not yet recruiting. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Hannover Medical School · Not applicable, Interventional, and Treatment
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's planned enrollment of 170 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
The treatment goal for the standard group is to achieve BP levels \<90th pct.
Other: Standard Treatment
Treatment goal in the intensified group will be lowering BP ≤60th pct.
Other: Intensified BP control
Treatment goal in the intensified group will be lowering BP ≤60th pct.
Standard treatment is to achieve BP levels \<90th pct.
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.
Time frame: At 24 months after randomization
Pulse Wave velocity (PWV)
PWV at 24 months after randomization.
Time frame: At 24 months after randomization
Estimated Glomerular Filtration Rate (eGFR)
eGFR estimated by the Schwartz bedside formula at 24 months after randomization.
Time frame: 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.
Time frame: At 24 months after randomization
Albuminuria
Albuminuria at 24 months after randomization. Albumine to creatinine ratio from spot urine will be assessed.
Time frame: At 24 months after randomization
No study locations are listed for this record.
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Plan to share: Undecided
Start is estimated for Sep 2024; primary completion for Sep 2028, 48 months later.
Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 48 months is above that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
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This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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