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The coArtHA trial-identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial
JournalArticle (Originalarbeit in einer wissenschaftlichen Zeitschrift)
ID
4646273
Author(s)
Mapesi, H.; Gupta, R.; Wilson, H. I.; Lukau, B.; Amstutz, A.; Lyimo, A.; Muhairwe, J.; Senkoro, E.; Byakuzana, T.; Mphunyane, M.; Bresser, M.; Glass, T. R.; Lambiris, M.; Fink, G.; Gingo, W.; Battegay, M.; Paris, D. H.; Rohacek, M.; Vanobberghen, F.; Labhardt, N. D.; Burkard, T.; Weisser, M.
The coArtHA trial-identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial
Journal
Trials
Volume
22
Number
1
Pages / Article-Number
77
Mesh terms
Antihypertensive Agents, adverse effects; Humans; Hypertension, drug therapy; Lesotho; Randomized Controlled Trials as Topic; Tanzania; Treatment Outcome
Abstract
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
