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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
Open accessPreprint — published as 10.1186/s13063-021-05023-z · Paper page
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. MethodsIn 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 ≥ 140/90mmHg. 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. DiscussionThis 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 registrationClinicaltrials.gov, NCT04129840. Registered on 17 October 2019 (https://www.clinicaltrials.gov/).
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CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
the CONSORT Group, Schulz, K. F., Altman, D. G., & Moher, D. (2010) · Trials · doi:10.1186/1745-6215-11-32 · Cited by 1,871
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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
- Published
- 2020-12-16
- Volume
- 22
- Issue
- 1
- Pages
- 77-77
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC7818218
- OpenAlex
- W3117003123
- Cited by
- 8
- References
- 1
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 2 · 2022: 3 · 2021: 1
- FWCI
- 1.01
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- 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
- National Science Foundation
- Universität Basel
- Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (185263, 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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