The purpose of this study to test whether n-of-1 trial-guided clinical decision-making improves blood pressure control in hypertensive children with chronic kidney disease (CKD) and end-stage renal disease (ESRD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
The n-of-1 trial will, on the level of the individual patient, test which treatment strategy produces superior blood pressure reduction without unacceptable side effects. After discussion with the patient/caregiver dyad to identify whether they have specific concerns about particular medications, the nephrologist (clinician) will decide which two drugs and dosages will be tested in the n-of-1 trial (the protocol does not determine drug or dose). The two drugs chosen by the clinician will be assessed at clinician-selected dosing in a randomized treatment order (e.g., ABAB) for two weeks per treatment period and two treatment periods per drug.
University of Texas at Houston Medical School; Pediatric Nephrology and Hypertension Clinics
Houston, Texas, United States
Change in 24-hour Mean Arterial Pressure (MAP)
24-hour mean arterial pressure (MAP) is the mean arterial pressure over 24 hours \[ambulatory blood pressure monitoring (ABPM) will be used to record blood pressure every 20 min for 24 hours, and all recordings will be averaged to obtain 24-hour MAP\]. 24-hour MAP will be assessed at baseline and at 6 months, and the change between baseline and 6-months will be reported.
Time frame: baseline, 6 months
Number of Participants With Target Blood Pressure
Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.
Time frame: 6 months
Number of Participants With Target Blood Pressure
Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.
Time frame: baseline
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