Abstract

Background: Ethnicity, along with a variety of genetic and environmental factors, is thought to influence the efficacy of anti-hypertensive therapies. Current UK guidelines employ a ‘black vs white’ approach; in doing so, they ignore the UK’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 multi-center, prospective, open-label, randomized study with two parallel, independent trial arms (mono- and dual-therapy), AIM-HY INFORM plans to enroll a total of 1320 patients from across the UK. Those receiving mono-therapy (n=660) will enter a three-treatment (Amlodipine 10 mg od; Lisinopril 20 mg od; Chlorthalidone 25 mg od), three-period crossover, lasting 24 weeks, whilst those receiving dual-therapy (n=660) will enter a four-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), four-period crossover, lasting 32 weeks. Equal numbers of three ethnic groups (White, Black/Black British, and Asian/Asian British) will ultimately be recruited to each of the trial arms (i.e., 220 participants per ethnic group per arm). Seated, automated, unattended, office, systolic blood pressure measured eight 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 anti-hypertensive therapies for multi-ethnic populations.