Faculty, Staff and Student Publications
Publication Date
2-13-2023
Journal
American Journal of Hypertention
Abstract
BACKGROUND: Blood pressure (BP) is often inadequately controlled in children treated for hypertension, and personalized (n-of-1) trials show promise for tailoring treatment choices. We assessed whether patients whose treatment choices are informed by an n-of-1 trial have improved BP control compared to usual care.
METHODS: A randomized clinical trial was conducted in a pediatric hypertension clinic in Houston from April 2018 to September 2020. Hypertensive adolescents and young adults 10-22 years old were randomized 1:1 to a strategy of n-of-1 trial using ambulatory BP monitoring to inform treatment choice or usual care, with treatment selected by physician preference. The primary outcome was the proportion of patients with ambulatory BP control at 6 months in a Bayesian analysis.
RESULTS: Among 49 participants (23 randomized to n-of-1 trials and 26 to usual care), mean age was 15.6 years. Using skeptical priors, we found a 69% probability that n-of-1 trials increased BP control at 6 months (Bayesian odds ratio (OR) 1.24 (95% credible interval (CrI) 0.51, 2.97), and 74% probability using neutral informed priors (OR 1.45 (95% CrI 0.48, 4.53)). Systolic BP was reduced in both groups, with a 93% probability of greater reduction in the n-of-1 trial group (mean difference between groups = -3.6 mm Hg (95% CrI -8.3, 1.28). There was no significant difference in side effect experience or caregiver satisfaction.
CONCLUSIONS: Among hypertensive adolescents and young adults, n-of-1 trials with ambulatory BP monitoring likely increased the probability of BP control. A large trial is needed to assess their use in clinical practice.
CLINICALTRIALS.GOV: NCT03461003.
CLINICAL TRIAL REGISTRY: ClinicalTrials.gov; NCT03461003.
Keywords
Adolescent, Young Adult, Humans, Child, Adult, Pilot Projects, Bayes Theorem, Hypertension, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Antihypertensive Agents
Included in
Cardiology Commons, Cardiovascular Diseases Commons, Internal Medicine Commons, Pediatrics Commons
Comments
Clinical Trials: NCT03461003
See " N-of-1 Trials for Pediatric Hypertension? A Promising Approach to Increasing the Precision of Antihypertensive Treatment" in volume 36 on page 87. See commentary " N-of-1 Trials for Pediatric Hypertension? A Promising Approach to Increasing the Precision of Antihypertensive Treatment" in volume 36 on page 87.Supplementary Materials
PMID: 36227203