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A randomized controlled cross-over 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 programme – AIM-HY INFORM trial

Published version
Peer-reviewed

Type

Article

Change log

Authors

Abstract

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.

Description

Keywords

Adolescent, Adult, Aged, Amlodipine, Antihypertensive Agents, Asian People, Black People, Chlorthalidone, Cross-Over Studies, Drug Administration Schedule, Drug Therapy, Combination, Hemodynamics, Humans, Hypertension, Lisinopril, Middle Aged, Prospective Studies, United Kingdom, White People, Young Adult

Journal Title

American Heart Journal

Conference Name

Journal ISSN

1097-6744
1097-6744

Volume Title

204

Publisher

Elsevier
Sponsorship
Cambridge University Hospitals NHS Foundation Trust (CUH) (unknown)
Cambridge University Hospitals NHS Foundation Trust (CUH) (146281)
MRC (via King's College London) (unknown)
MRC (via King's College London) (N/K)
British Heart Foundation (None)
British Heart Foundation (None)
British Heart Foundation (None)
The AIM-HY programme is co-funded by the Medical Research Council and British Heart Foundation (MRC Reference: MR/M016560/1). IBW, CMM and JC acknowledge funding support from the NIHR Cambridge Comprehensive Biomedical Research Centre.