Dike B Ojji1, Neil Poulter2, Albertino Damasceno3, Karen Sliwa4, Wynand Smythe5, Nicky Kramer5, Motasim Badri6, Veronica Francis5, Akinyemi Aje7, Felix Barasa8, Anastase Dzudie9, Erika Jones10, Shehu S Kana11, Pindile Mntla12, Charles Mondo13, Okechukwu Ogah7, Elijah N Ogola14, Gboyega Ogunbanjo15, Ikechi Okpechi10, Gabriel Shedul16, Mahmoud U Sani17, Grace Shedul18, Bongani M Mayosi19. 1. Department of Medicine, Faculty of Clinical Sciences, University of Abuja/University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria. 2. Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, United Kingdom. 3. Eduardo Mondlane University Hospital, Maputo, Mozambique. 4. Hatter Institute of Cardiovascular Research in Africa, Cape Town, South Africa. 5. Clinical Research Centre, Faculty of Clinical Sciences, University of Cape Town, Cape Town, South Africa. 6. Department of Basic Sciences, College of Sciences & Health Professions King Saud Bin Abdul-Aziz University for Health Sciences NGHA, Riyadh, Saudi Arabia; Department of Medicine, Faculty of Clinical Sciences, University of Cape Town, Cape Town, South Africa. 7. University College Hospital, Ibadan, Nigeria. 8. MOI University Hospital, Eldoret, Kenya. 9. Douala General Hospital, Douala, Cameroon. 10. Department of Medicine, Faculty of Clinical Sciences, University of Cape Town, Cape Town, South Africa. 11. Department of Medicine, Aminu Kano Teaching Hospital, Kano, Nigeria. 12. Department of Cardiology, Sefako Makgatho Health Sciences University, Pretoria, South Africa. 13. St Francis Hospital, Nsambya, Kampala, Uganda. 14. Department of Clinical Medicine and Therapeutics, University of Nairobi, Nairobi, Kenya. 15. Department of Family Medicine & Primary Health Care, Sefako Makgatho Health Sciences University, Pretoria, South Africa. 16. Department of Family Medicine, University of Abuja Teaching Hospital, Gwagwalada, Abuja. 17. Aminu Kano Teaching Hospital, Kano, Nigeria. 18. Department of Pharmacy, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria. 19. Department of Medicine, Faculty of Clinical Sciences, University of Cape Town, Cape Town, South Africa. Electronic address: bongani.mayosi@uct.ac.za.
Abstract
BACKGROUND: Current hypertension guidelines recommend the use of combination therapy as first-line treatment or early in the management of hypertensive patients. Although there are many possible combinations of blood pressure(BP)-lowering therapies, the best combination for the black population is still a subject of debate because no large randomized controlled trials have been conducted in this group to compare the efficacy of different combination therapies to address this issue. METHODS: The comparison of 3 combination therapies in lowering BP in the black Africans (CREOLE) study is a randomized single-blind trial that will compare the efficacy of amlodipine plus hydrochlorothiazide versus amlodipine plus perindopril and versus perindopril plus hydrochlorothiazide in blacks residing in sub-Saharan Africa (SSA). Seven hundred two patients aged 30-79 years with a sitting systolic BP of 140 mm Hg and above, and less than 160 mm Hg on antihypertensive monotherapy, or sitting systolic BP of 150 mm Hg and above, and less than 180 mm Hg on no treatment, will be centrally randomized into any of the 3 arms (234 into each arm). The CREOLE study is taking place in 10 sites in SSA, and the primary outcome measure is change in ambulatory systolic BP from baseline to 6 months. The first patient was randomized in June 2017, and the trial will be concluded by 2019. CONCLUSIONS: The CREOLE trial will provide unique information as to the most efficacious 2-drug combination in blacks residing in SSA and thereby inform the development of clinical guidelines for the treatment of hypertension in this subregion.
RCT Entities:
BACKGROUND: Current hypertension guidelines recommend the use of combination therapy as first-line treatment or early in the management of hypertensivepatients. Although there are many possible combinations of blood pressure(BP)-lowering therapies, the best combination for the black population is still a subject of debate because no large randomized controlled trials have been conducted in this group to compare the efficacy of different combination therapies to address this issue. METHODS: The comparison of 3 combination therapies in lowering BP in the black Africans (CREOLE) study is a randomized single-blind trial that will compare the efficacy of amlodipine plus hydrochlorothiazide versus amlodipine plus perindopril and versus perindopril plus hydrochlorothiazide in blacks residing in sub-Saharan Africa (SSA). Seven hundred two patients aged 30-79 years with a sitting systolic BP of 140 mm Hg and above, and less than 160 mm Hg on antihypertensive monotherapy, or sitting systolic BP of 150 mm Hg and above, and less than 180 mm Hg on no treatment, will be centrally randomized into any of the 3 arms (234 into each arm). The CREOLE study is taking place in 10 sites in SSA, and the primary outcome measure is change in ambulatory systolic BP from baseline to 6 months. The first patient was randomized in June 2017, and the trial will be concluded by 2019. CONCLUSIONS: The CREOLE trial will provide unique information as to the most efficacious 2-drug combination in blacks residing in SSA and thereby inform the development of clinical guidelines for the treatment of hypertension in this subregion.
Authors: Martin Muddu; Fred C Semitala; Isaac Kimera; Mary Mbuliro; Rebecca Ssennyonjo; Simon P Kigozi; Rodgers Katwesigye; Florence Ayebare; Christabellah Namugenyi; Frank Mugabe; Gerald Mutungi; Chris T Longenecker; Anne R Katahoire; Isaac Ssinabulya; Jeremy I Schwartz Journal: BMC Health Serv Res Date: 2022-05-25 Impact factor: 2.908
Authors: Prossie Merab Ingabire; Dike B Ojji; Brian Rayner; Elijah Ogola; Albertino Damasceno; Erika Jones; Anastase Dzudie; Okechukwu S Ogah; Neil Poulter; Mahmoud U Sani; Felix Ayub Barasa; Grace Shedul; John Mukisa; David Mukunya; Bonnie Wandera; Charles Batte; James Kayima; Shahiemah Pandie; Charles Kiiza Mondo Journal: BMC Cardiovasc Disord Date: 2021-05-22 Impact factor: 2.298