The coArtHA trial\u2014identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial

Herry Mapesi,Ravi Gupta,Elizabeth Senkoro,Günther Fink,Herieth Wilson ,Blaise Lukau,Alain Amstutz,Daniel Paris ,Manuel Battegay,Niklaus Daniel Labhardt,Fiona Vanobberghen,Aza Lyimo,Martin Rohacek,Moniek Bresser,Winfrid Gingo,Mark Lambiris,Madavida Mphunyane,Josephine Muhairwe,Thilo Burkard,Theonestina Byakuzana,Tracy R Glass ,Maja Weisser

doi:10.1186/s13063-021-05023-z

Abstract

BackgroundArterial hypertension is the most prevalent risk factor for cardiovascular disease in sub-Saharan Africa. Only a few and mostly small randomized trials have studied antihypertensive treatments in people of African descent living in sub-Saharan Africa.MethodsIn this open-label, three-arm, parallel randomized controlled trial conducted at two rural hospitals in Lesotho and Tanzania, we compare the efficacy and cost-effectiveness of three antihypertensive treatment strategies among participants aged ≥ 18 years. The study includes patients with untreated uncomplicated arterial hypertension diagnosed by a standardized office blood pressure ≥ 140/90 mmHg. The trial encompasses a superiority comparison between a triple low-dose antihypertensive drug combination versus the current standard of care (monotherapy followed by dual treatment), as well as a non-inferiority comparison for a dual drug combination versus standard of care with optional dose titration after 4 and 8 weeks for participants not reaching the target blood pressure. The sample size is 1268 participants with parallel allocation and a randomization ratio of 2:1:2 for the dual, triple and control arms, respectively. The primary endpoint is the proportion of participants reaching a target blood pressure at 12 weeks of ≤ 130/80 mmHg and ≤ 140/90 mmHg among those aged < 65 years and ≥ 65 years, respectively. Clinical manifestations of end-organ damage and cost-effectiveness at 6 months are secondary endpoints.DiscussionThis trial will help to identify the most effective and cost-effective treatment strategies for uncomplicated arterial hypertension among people of African descent living in rural sub-Saharan Africa and inform future clinical guidelines on antihypertensive management in the region.Trial registrationClinicaltrials.govNCT04129840. Registered on 17 October 2019 (https://www.clinicaltrials.gov/).

Highlights

Arterial hypertension is the most prevalent risk factor for cardiovascular disease in sub-Saharan Africa
Despite the high burden in Africa, there are still few clinical trials evaluating the best treatment for arterial hypertension in sub-Saharan Africa [41]
A recent randomized controlled trial found that calcium channel blocker (CCB)-containing regimens were superior compared to a combination of diuretics and ACEinhibitors among Africans [29]

Summary

Introduction

Arterial hypertension is the most prevalent risk factor for cardiovascular disease in sub-Saharan Africa. The most important risk factor for cardiovascular disease in sub-Saharan Africa is arterial hypertension with a prevalence of 30–46% [3,4,5,6,7,8,9] and an age-standardized mean systolic blood pressure (BP) being 5–20 mmHg higher compared to North America or Europe [1]. Despite the high burden of arterial hypertension in sub-Saharan Africa, less than 40% of hypertensive patients are aware of their diagnosis Among those who are aware of their diagnosis, less than 30% are receiving antihypertensive medications and less than 20% of those being treated have a controlled BP [6, 16]

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