At a glance
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A Randomized Clinical Trial of the N-of-1 Approach in Children With Hypertension
In Brief
A Phase 4 clinical trial evaluating NICHE method, Usual care, and 4 other interventions for Pediatric Hypertension. Completed, enrolled 49 participants across 1 site.
Detailed Summary
The single patient (n-of-1) randomized trial is an underused approach to resolving therapeutic uncertainty by using a patient's own data to inform an individualized treatment plan. The proposed research is designed to assess whether the n-of-1 trial approach improves blood pressure control compared to usual care. This trial aims to advance learning about not only the treatment of pediatric hypertension but also the use of a neglected type of randomized trial to optimize the care of each patient.
Study Details
Timeline
Interventions
Based on underlying comorbidities at enrollment, patients will be assigned to either an unrestricted protocol (amlodipine versus lisinopril) or a restricted protocol (losartan versus lisinopril). Two drugs are tested in randomized order. Failure to achieve BP control at maximum doses of the first two drugs will result in augmentation with a diuretic (hydrochlorothiazide). BP control is assessed with 24 hour ambulatory monitoring at the end of each 2 week treatment period. Side effect tolerability is assessed with a questionnaire.
Physician preference will dictate choice and adjustment of antihypertensive medication, BP measurement modality, interval between visits, and assessment of side effects.
Calcium-channel blocker; antihypertensive
Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive
Thiazide diuretic; antihypertensive
Angiotensin II receptor blocker (ARB); antihypertensive