N-of-1 Trials In Children With Hypertension
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. This trial will 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.
- Pediatric Hypertension
- Eligible Ages
- Between 10 Years and 22 Years
- Eligible Genders
- Accepts Healthy Volunteers
- treating physician determines that pharmacologic therapy is indicated for treatment of hypertension
- ambulatory hypertension has been confirmed (off meds) within 12 months of enrollment
- age < 10 years
- resistant hypertension (requiring ≥ 3 drug therapy)
- absolute contraindication or allergy to any of the tested drugs.
- Phase 4
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Single (Outcomes Assessor)
|In the NICHE method, antihypertensive therapy will be chosen using an n-of-trial to identify the preferred therapy. Preferred therapy is defined a priori as that which produces the greatest reduction in ambulatory BP without intolerable side effects. Tested drugs will include amlodipine or losartan, lisinopril, and hydrochlorothiazide.||
|No protocol will be introduced to standardize BP management in the control arm.||
- The University of Texas Health Science Center, Houston
Study ContactJoyce P Samuel, MD, MS
Pediatric hypertension, a growing problem, often requires prescription of antihypertensive medication. Pediatric hypertension specialists lack an evidentiary base on which to establish definitive clinical practice guidelines for first-line therapy. Significant practice variation is an unsurprising consequence. Routine choice of the same first-line therapy for most patients with hypertension, absent testing other options, may delay correction of blood pressure for months or years. Failure to incorporate patient preferences in medical decision-making may also contribute to decreased patient satisfaction and adherence.
Large parallel-group, comparative effectiveness trials are likely not on the horizon for this population. Moreover, heterogeneity of treatment effects would minimize the generalizability of such a trial to all patients.
This is a parallel-group, randomized clinical trial to test whether the n-of-1 trial approach is superior to usual care in normalizing blood pressure while minimizing exposure to compliance-reducing side effects.