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

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

BACKGROUND: Arterial 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. METHODS: In 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. DISCUSSION: This 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 REGISTRATION: Clinicaltrials.govNCT04129840. Registered on 17 October 2019 (https://www.clinicaltrials.gov/).