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

• Published in: Current controlled trials in cardiovascular medicine 2021-01, Vol.22 (1), p.77-77, Article 77
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Age; Antihypertensive drugs; Antihypertensive therapy; Antihypertensives; Arterial hypertension; Blood pressure; Chronic illnesses; Clinical practice guidelines; Cost analysis; Creatinine; Drug dosages; Drug therapy; Drug therapy, Combination; Ethnicity; Heart attacks; HIV; Hospitals; Human immunodeficiency virus; Hypertension; Kidney diseases; Medical referrals; Medical tests; Performance evaluation; Pregnancy; Questionnaires; Randomized controlled trial; Stroke; Study Protocol; Sub-Saharan Africa; Testing
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05023-z

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. 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