Thilo Burkard1,2, Maja Weisser3,4,5,6, Herry Mapesi7,8,9, Ravi Gupta10, Herieth Ismael Wilson7, Blaise Lukau10, Alain Amstutz8,9,11, Aza Lyimo12,13, Josephine Muhairwe10, Elizabeth Senkoro7, Theonestina Byakuzana7, Madavida Mphunyane14, Moniek Bresser8,9, Tracy Renée Glass8,9, Mark Lambiris8,9, Günther Fink8,9, Winfrid Gingo12, Manuel Battegay9,11, Daniel Henry Paris8,9, Martin Rohacek7,8,9,12, Fiona Vanobberghen8,9, Niklaus Daniel Labhardt8,9,11. 1. Medical Outpatient and Hypertension Clinic, ESH Hypertension Centre of Excellence, University Hospital Basel, Basel, Switzerland. 2. Department of Cardiology, University Hospital Basel, Basel, Switzerland. 3. Ifakara Health Institute, Ifakara branch, Ifakara, United Republic of Tanzania. maja.weisser@usb.ch. 4. Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland. maja.weisser@usb.ch. 5. University of Basel, Basel, Switzerland. maja.weisser@usb.ch. 6. Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland. maja.weisser@usb.ch. 7. Ifakara Health Institute, Ifakara branch, Ifakara, United Republic of Tanzania. 8. Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland. 9. University of Basel, Basel, Switzerland. 10. SolidarMed, Partnerships for Health, Maseru, Lesotho. 11. Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland. 12. St. Francis Referral Hospital, Ifakara, United Republic of Tanzania. 13. Tanzania Training Center for International Health, Ifakara, United Republic of Tanzania. 14. Ministry of Health, Maseru, Lesotho.
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/ ).
RCT Entities:
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/ ).
Entities:
Keywords:
Antihypertensive therapy; Arterial hypertension; Blood pressure; Dual therapy; HIV; Randomized controlled trial; Sub-Saharan Africa; Tanzania and Lesotho; Triple therapy
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