Trials (Jan 2021)

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

  • 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

DOI
https://doi.org/10.1186/s13063-021-05023-z
Journal volume & issue
Vol. 22, no. 1
pp. 1 – 12

Abstract

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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/ ).

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