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:10.1186/s13063-021-05023-z

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^*

^*Corresponding author for this work

Bristol Medical School (PHS)

Research output: Contribution to journal › Article (Academic Journal) › peer-review

7 Citations (Scopus)

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.govNCT04129840. Registered on 17 October 2019 (https://www.clinicaltrials.gov/).

Original language	English
Pages (from-to)	77
Number of pages	12
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-021-05023-z
Publication status	Published - 21 Jan 2021

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Antihypertensive Agents/adverse effects
Humans
Hypertension/diagnosis
Lesotho
Randomized Controlled Trials as Topic
Tanzania
Treatment Outcome

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10.1186/s13063-021-05023-zLicence: CC BY

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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., ... Weisser, M. (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. Trials, 22(1), 77. https://doi.org/10.1186/s13063-021-05023-z

@article{0592a3cd1d8d4159bf2bf33f1d5bdf7f,

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

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.govNCT04129840. Registered on 17 October 2019 (https://www.clinicaltrials.gov/).",

keywords = "Antihypertensive Agents/adverse effects, Humans, Hypertension/diagnosis, Lesotho, Randomized Controlled Trials as Topic, Tanzania, Treatment Outcome",

author = "Herry Mapesi and Ravi Gupta and Wilson, \{Herieth Ismael\} and Blaise Lukau and Alain Amstutz and Aza Lyimo and Josephine Muhairwe and Elizabeth Senkoro and Theonestina Byakuzana and Madavida Mphunyane and Moniek Bresser and Glass, \{Tracy Ren{\'e}e\} and Mark Lambiris and G{\"u}nther Fink and Winfrid Gingo and Manuel Battegay and Paris, \{Daniel Henry\} and Martin Rohacek and Fiona Vanobberghen and Labhardt, \{Niklaus Daniel\} and Thilo Burkard and Maja Weisser",

year = "2021",

month = jan,

day = "21",

doi = "10.1186/s13063-021-05023-z",

language = "English",

volume = "22",

pages = "77",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd",

number = "1",

}

Mapesi, H, Gupta, R, Wilson, HI, Lukau, B, Amstutz, A, Lyimo, A, Muhairwe, J, Senkoro, E, Byakuzana, T, Mphunyane, M, Bresser, M, Glass, TR, Lambiris, M, Fink, G, Gingo, W, Battegay, M, Paris, DH, Rohacek, M, Vanobberghen, F, Labhardt, ND, Burkard, T & Weisser, M 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', Trials, vol. 22, no. 1, pp. 77. https://doi.org/10.1186/s13063-021-05023-z

TY - JOUR

T1 - The coArtHA trial-identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa

T2 - study protocol for a randomized controlled trial

AU - Mapesi, Herry

AU - Gupta, Ravi

AU - Wilson, Herieth Ismael

AU - Lukau, Blaise

AU - Amstutz, Alain

AU - Lyimo, Aza

AU - Muhairwe, Josephine

AU - Senkoro, Elizabeth

AU - Byakuzana, Theonestina

AU - Mphunyane, Madavida

AU - Bresser, Moniek

AU - Glass, Tracy Renée

AU - Lambiris, Mark

AU - Fink, Günther

AU - Gingo, Winfrid

AU - Battegay, Manuel

AU - Paris, Daniel Henry

AU - Rohacek, Martin

AU - Vanobberghen, Fiona

AU - Labhardt, Niklaus Daniel

AU - Burkard, Thilo

AU - Weisser, Maja

PY - 2021/1/21

Y1 - 2021/1/21

N2 - 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.govNCT04129840. Registered on 17 October 2019 (https://www.clinicaltrials.gov/).

AB - 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.govNCT04129840. Registered on 17 October 2019 (https://www.clinicaltrials.gov/).

KW - Antihypertensive Agents/adverse effects

KW - Humans

KW - Hypertension/diagnosis

KW - Lesotho

KW - Randomized Controlled Trials as Topic

KW - Tanzania

KW - Treatment Outcome

U2 - 10.1186/s13063-021-05023-z

DO - 10.1186/s13063-021-05023-z

M3 - Article (Academic Journal)

C2 - 33478567

SN - 1745-6215

VL - 22

SP - 77

JO - Trials

JF - Trials

IS - 1

ER -

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

Abstract

UN SDGs

Keywords

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