Results
ADVERSE EVENTS
Between Oct 30, 2012, and Jan 5, 2017, 64 participants were randomly assigned to the intensive treatment group and 60 to the standard treatment group, and were included in the intention-to-treat population (Trial profileAt the final follow-up visit, the majority of patients had not reached 5 years of study participation, which accounts for the sharp decrease in numbers available for follow-up between year 4 and 5. ACE=angiotensin-converting enzyme. ARB=angiotensin receptor blocker.Baseline characteristics of the intention-to-treat populationData are median (IQR), n (%), or mean (SD). Percentages might not sum to 100 as a result of rounding.Assessed in 21 patients in the intensive treatment group and 25 patients in the standard therapy group.Throughout follow-up, the mean office systolic blood pressure was 103 mm Hg (SD 10) in the intensive treatment group versus 107 mm Hg (10) in the standard treatment group (p=0·0012), mean office diastolic blood pressure was 60 mm Hg (10) versus 64 mm Hg (12; p=0·0003), and mean arterial pressure was 75 mm Hg (9) versus 78 mm Hg (10; p=0·0001), with a mean systolic blood pressure Z score of 0·06 (0·88) versus 0·19 (0·80) and a mean diastolic blood pressure Z score of –0·27 (1·09) versus 0·01 (1·16). Over the course of the study, the number of antihypertensive medications prescribed per patient was higher in the intensive treatment group than in the standard treatment group, with a mean difference between groups of 0·50 (95% CI 0·25 to 0·75, p<0·0001; Participants were matched for most echocardiographic measures at baseline (There was a sustained reduction in LVMI over the course of the trial, but the difference between groups did not reach statistical significance (LVMI and relative wall thickness over time(A) Change in mean LVMI from baseline. Data are shown as mean, with error bars indicating 95% CIs. (B) Change in mean relative wall thickness, defined as from baseline. Data are shown as mean, with error bars indicating 95% CIs. Means were estimated by use of a linear mixed-effects model for repeated measures. LVMI=left ventricular mass index.Left ventricular mass over time in the intention-to-treat populationAt the final follow-up visit, the majority of patients had not reached 5 years of study participation, which accounts for the sharp decrease in numbers available for follow-up between year 4 and 5. LVMI=left ventricular mass index.The p value denotes difference between the two groups in change in mean LVMI per year.Unless otherwise stated.The two treatment strategies resulted in a reduction in relative wall thickness over time (Relative wall thickness over time in the intention-to-treat populationRelative wall thickness is defined as two times posterior wall thickness divided by the left ventricular diastolic diameter. At the final follow-up visit, the majority of patients had not reached 5 years of study participation, which accounts for the sharp decrease in numbers available for follow-up between year 4 and 5.The p value denotes difference between the two groups in change in the mean relative wall thickness per year.Unless otherwise stated.133 adverse events occurred over the course of the trial of which 15 were serious adverse advents (Safety and renal outcomes related to the blood pressure in the intention-to-treat populationData are n (%) or n/N (%). eGFR=estimated glomerular filtration rate.Resulted in withdrawal from the study.Changed from an angiotensin-converting enzyme inhibitor to angiotensinogen receptor blocker.Two episodes in the same child.Same child (who eventually underwent circumcision).Three episodes in same child.Over the course of the study, the mean difference in eGFR between the intensive treatment group and the standard treatment group was –3·9 mL/min per 1·73 m