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 - 30/10/18
, Joseph Cheriyan, FRCP b, John R. Cockcroft, FESC c, David Collier, PhD d, James M. Coulson, MD e, Indranil Dasgupta, FRCP f, Luca Faconti, MBBS g, Mark Glover, PhD h, Anthony M. Heagerty, FMedSci i, Teck K. Khong, FRCP j, Gregory Y.H. Lip, MD k, Adrian P. Mander, PhD l, Mellone N. Marchong, PhD m, Una Martin, FRCPI n, Barry J. McDonnell, PhD o, Carmel M. McEniery, PhD a, Sandosh Padmanabhan, FRCP p, Manish Saxena, MBBS d, Peter J. Sever, FRCP q, Julian I. Shiel, MB, BCh d, Julie Wych, PhD l, Phil J. Chowienczyk, FRCP g, Ian B. Wilkinson, DM rAbstract |
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.
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| Conflicts of interest statement: The authors certify that they have no affiliations with or involvement in any organization or entity with any pecuniary interest or nonpecuniary interest in the subject matter or materials discussed in this manuscript. |
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| RCT# NCT02847338 |
Vol 204
P. 102-108 - octobre 2018 Retour au numéro
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