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

• Main Authors: Herry Mapesi, Ravi Gupta, Herieth Ismael Wilson, Blaise Lukau, Alain Amstutz, Aza Lyimo, Josephine Muhairwe, Elizabeth Senkoro, Theonestina Byakuzana, Madavida Mphunyane, Moniek Bresser, Tracy Renée Glass, Mark Lambiris, Günther Fink, Winfrid Gingo, Manuel Battegay, Daniel Henry Paris, Martin Rohacek, Fiona Vanobberghen, Niklaus Daniel Labhardt, Thilo Burkard, Maja Weisser
• Format: Article
• Language: English
• Published: BMC 2021-01-01
• Series: Trials
• Subjects: Arterial hypertension; Blood pressure; Antihypertensive therapy; Randomized controlled trial; Sub-Saharan Africa; HIV
• Online Access: https://doi.org/10.1186/s13063-021-05023-z

Abstract 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.gov NCT04129840 . Registered on 17 October 2019 ( https://www.clinicaltrials.gov/ ).