A randomized controlled crossover trial evaluating differential responses to antihypertensive drugs (used as mono- or dual therapy) on the basis of ethnicity: the comparIsoN oF Optimal Hypertension RegiMens; part of the Ancestry Informative Markers in HYpertension program—AIM-HY INFORM trial

Mukhtar, Omar; Cheriyan, Joseph; Cockcroft, John R.; Collier, David; Coulson, James M.; Dasgupta, Indranil; Faconti, Luca; Glover, Mark; Heagerty, Anthony M.; Khong, Teck K.; Lip, Gregory Y.H.; Mander, Adrian P.; Marchong, Mellone N.; Martin, Una; McDonnell, Barry J.; McEniery, Carmel M.; Padmanabhan, Sandosh; Saxena, Manish; Sever, Peter J.; Shiel, Julian I.; Wych, Julie; Chowienczyk, Phil J.; Wilkinson, Ian B.

Abstract

BACKGROUND: Ethnicity, along with a variety of genetic and environmental factors, is thought to influence the efficacy of antihypertensive therapies. Current UK guidelines use a "black versus white" approach; in doing so, they ignore the United Kingdom's largest ethnic minority: Asians from South Asia.
STUDY DESIGN: The primary purpose of the AIM-HY INFORM trial is to identify potential differences in response to antihypertensive drugs used as mono- or dual therapy on the basis of self-defined ethnicity. A multicenter, prospective, open-label, randomized study with 2 parallel, independent trial arms (mono- and dual therapy), AIM-HY INFORM plans to enroll a total of 1,320 patients from across the United Kingdom. Those receiving monotherapy (n = 660) will enter a 3-treatment (amlodipine 10 mg od; lisinopril 20 mg od; chlorthalidone 25 mg od), 3-period crossover, lasting 24 weeks, whereas those receiving dual therapy (n = 660) will enter a 4-treatment (amlodipine 5 mg od and lisinopril 20 mg od; amlodipine 5 mg od and chlorthalidone 25 mg od; lisinopril 20 mg od and chlorthalidone 25 mg od; amiloride 10 mg od and chlorthalidone 25 mg od), 4-period crossover, lasting 32 weeks. Equal numbers of 3 ethnic groups (white, black/black British, and Asian/Asian British) will ultimately be recruited to each of the trial arms (ie, 220 participants per ethnic group per arm). Seated, automated, unattended, office, systolic blood pressure measured 8 weeks after each treatment period begins will serve as the primary outcome measure.
CONCLUSION: AIM-HY INFORM is a prospective, open-label, randomized trial which aims to evaluate first- and second-line antihypertensive therapies for multiethnic populations.

Citation

Mukhtar, O., Cheriyan, J., Cockcroft, J. R., Collier, D., Coulson, J. M., Dasgupta, I., …Wilkinson, I. B. (2018). A randomized controlled crossover trial evaluating differential responses to antihypertensive drugs (used as mono- or dual therapy) on the basis of ethnicity: the comparIsoN oF Optimal Hypertension RegiMens; part of the Ancestry Informative Markers in HYpertension program—AIM-HY INFORM trial. American Heart Journal, 204, 102-108. https://doi.org/10.1016/j.ahj.2018.05.006

• Journal Article Type: Article
• Acceptance Date: May 18, 2018
• Online Publication Date: May 20, 2018
• Publication Date: Oct 1, 2018
• Deposit Date: Nov 21, 2018
• Publicly Available Date: Nov 22, 2018
• Journal: American Heart Journal
• Print ISSN: 0002-8703
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 204
• Pages: 102-108
• DOI: https://doi.org/10.1016/j.ahj.2018.05.006
• Keywords: Cardiology and Cardiovascular Medicine
• Public URL: https://nottingham-repository.worktribe.com/output/1296590
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S000287031830156X?via%3Dihub