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Cited by 8Blood Pressure and Hypertension StudiesCardiovascular Health and Disease PreventionClinical practice guidelines implementation

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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

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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·2021·Trials
DOI 10.1186/s13063-021-05023-zPMC PMC7818218

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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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Metadata

Authors
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.
Affiliations
  • Ifakara Health Institute (TZ)
  • SolidarMed (CH)
  • Swiss Tropical and Public Health Institute (CH)
  • St. Francis Referral Hospital (TZ)
  • Ministry of Health (LS)
  • University of Basel (CH)
  • University Hospital of Basel (CH)
Corresponding author
Weisser, Maja
ORCID
Venue
Trials
Publisher
Springer Science and Business Media LLC
Published
2021-01-21
Volume
22
Issue
1
Pages
77-77
ISSN
1745-6215 (ISSN-L)
DOI
10.1186/s13063-021-05023-z
PMC
PMC7818218
OpenAlex
W3117003123
Cited by
8
References
9
Citations by year
2026: 1 · 2025: 1 · 2024: 2 · 2022: 3 · 2021: 1
Type
conference abstract
Language
en
Open access
Licence
Locations
  • Trials (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • edoc (University of Basel) (acceptedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Explore Bristol Research (submittedVersion, cc-by)
  • Bristol Research (University of Bristol) (submittedVersion, cc-by)
  • edoc (University of Basel)
Funders
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (32003B_185263/1)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
Keywords
hypertension, antihypertensive therapy, monotherapy, dose titration, blood pressure control, cost-effectiveness, Afro-descendants, sub-Saharan Africa, rural population, target organ damage, cardiovascular risk
MeSH terms
Equivalence Trials as Topic, Antihypertensive Agents, Humans, Hypertension, Lesotho, Tanzania, Randomized Controlled Trials as Topic, Treatment Outcome

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