coArtHA 试验——确定控制撒哈拉以南非洲地区动脉高血压的最有效治疗策略：一项随机对照试验的研究方案。

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

机构信息

Ifakara Health Institute, Ifakara branch, Ifakara, United Republic of Tanzania.

Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland.

出版信息

Trials. 2021 Jan 21;22(1):77. doi: 10.1186/s13063-021-05023-z.

DOI:10.1186/s13063-021-05023-z

PMID:33478567

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7818218/

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/ ).

摘要

背景

动脉高血压是撒哈拉以南非洲地区心血管疾病最普遍的风险因素。只有少数且大多是小型随机试验研究了居住在撒哈拉以南非洲的非洲裔人群的抗高血压治疗方法。

方法

在莱索托和坦桑尼亚的两家农村医院进行的这项开放性、三臂、平行随机对照试验中，我们比较了三种降压治疗策略在年龄≥18 岁的参与者中的疗效和成本效益。该研究包括未经治疗的单纯性动脉高血压患者，通过标准化诊室血压测量，收缩压≥140mmHg 和/或舒张压≥90mmHg 进行诊断。试验包括三种降压药物低剂量三联疗法与当前标准治疗（单药治疗后双联治疗）的优越性比较，以及双联药物与标准治疗的非劣效性比较，对于未达到目标血压的患者，在 4 周和 8 周后可选择进行剂量滴定。样本量为 1268 名参与者，平行分配，双药组、三药组和对照组的随机分组比例分别为 2:1:2。主要终点是在 12 周时年龄<65 岁和≥65 岁的参与者中，达到≤130/80mmHg 和≤140/90mmHg 目标血压的比例。6 个月时的终点是临床终点和成本效益。