drugset / Trial / NCT03461003
N-of-1 Trials In Children With Hypertension
Phase 4
Completed
49 enrolled
The University of Texas Health Science Center, Houston
National Center for Advancing Translational Sciences (NCATS) · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2018-04-02
- Primary completion
- 2020-11-14
- Completion
- 2021-05-02
Publications
- Background Flynn JT, Daniels SR, Hayman LL, Maahs DM, McCrindle BW, Mitsnefes M, Zachariah JP, Urbina EM; American Heart Association Atherosclerosis, Hypertension and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Update: ambulatory blood pressure monitoring in children and adolescents: a scientific statement from the American Heart Association. Hypertension. 2014 May;63(5):1116-35. doi: 10.1161/HYP.0000000000000007. Epub 2014 Mar 3. No abstract available.
- Samuel JP, Bell CS, Samuels JA, Rajan C, Walton AK, Green C, Tyson JE. N-of-1 Trials vs. Usual Care in Children With Hypertension: A Pilot Randomized Clinical Trial. Am J Hypertens. 2023 Feb 13;36(2):126-132. doi: 10.1093/ajh/hpac117.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | — | — |
| Subject | Hydrochlorothiazide | Unknown | — | — |
| Subject | LISINOPRIL ANHYDROUS | Small molecule | — | — |
| Subject | Losartan | Other / unclassified | — | — |