NCT04129840已完成不适用
Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa - A Randomized Controlled Trial
University Hospital, Basel, Switzerland4 个研究点 分布在 3 个国家目标入组 1,268 人开始时间: 2020年3月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,268
- 试验地点
- 4
- 主要终点
- Proportion of patients reaching a target blood pressure
研究概览
简要总结
This study is to compare the effectiveness of three different antihypertensive treatment strategies for reaching a target blood pressure (clinic BP) of </= 130/80 mmHg among patients <65years of age and </= 140/90 mmHg among patients >/=65years of Age in HIV-positive and HIV-negative patients with uncomplicated arterial hypertension in rural Tanzania and Lesotho.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-positive and negative patients of African descent and black ethnicity with a documented uncomplicated, untreated arterial hypertension (blood pressure >/=140/90 mmHg) diagnosed at one of the 2 study sites
排除标准
- •Current hospitalization for any reason
- •Not of African descent
- •Refusal of an HIV-test or indeterminate HIV test result
- •History of cardiovascular event in the last month (anginal pain, stroke, myocardial infarction or diagnosis by a doctor)
- •Symptomatic arterial hypertension (blood pressure >/=180/110 mmHg plus headache or chest pain) or acute cardiovascular event
- •acute disease, (e.g. fever >37.5°C or other signs of acute concomitant infection; Dyspnea/respiratory distress; Acute pain)
- •Clinical signs of hypertension-mediated organ damage (heart failure, bilateral pitting edema, bilateral crackles or pleural effusion, distended jugular veins, ischemic heart disease (anginal pain on exertion), signs of current ischemic/hemorrhagic stroke (hemiparesis, loss of consciousness)
- •Pregnancy (test required for females 18-45years of age)
- •Non-consenting or inability to come for follow-up visits
- •creatinine clearance </=30ml/min by Chronic Kidney Disease Epidemiology Formula (CK-EPI) estimation and measurement with a point-of care creatinine from capillary blood
结局指标
主要结局
Proportion of patients reaching a target blood pressure
时间窗: at 12 weeks after enrolment
Proportion of patients reaching a target blood pressure (clinic blood pressure) of \</=130/80 mmHg in patients \<65years of age and \</=140/90 mmHg in patients \>65years of age
次要结局
- Proportion of patients with treatment adaptations made to the primary treatment(within 12 weeks after enrolment)
- Time until first target blood pressure of </=130/80 mmHg in patients <65years of age and </=140/90mmHg in patients >65years of age(within 24 weeks after enrolment)
- Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement(within 12 weeks after enrolment)
- Reasons for non-adherence assessed by self-report (descriptive analysis)(within 24 weeks after enrolment)
- Change in blood pressure (mmHg)(at 4, 8, 12, 24 weeks after enrolment)
- Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage(within 24 weeks after enrolment)
- Proportion of patients who were non-adherent to drugs(at 12 weeks after enrolment)
- Cost-effectiveness of the 3 treatment algorithms(within 24 weeks after enrolment)
- Proportion of patients with blood pressure control determined by 24h ambulatory blood pressure measurement (24h mean blood pressure <130/80mmHg irrespective of age)(within 12 weeks after enrolment)
- Number of treatment adaptations per patient made to the primary treatment(within 12 weeks after enrolment)
- Proportion of patients lost to follow up or stopped treatment(within 24 weeks after enrolment)
- Proportion of patients with at least one grade 3/4 adverse event(within 24 weeks after enrolment)
- Reasons for non-adherence assessed by pill count (descriptive analysis)(within 24 weeks after enrolment)
- Proportion of patients reaching a target blood pressure(at 4, 8 and 24 weeks after enrolment)
- Proportion of patients with major cardiovascular endpoints(within 24 weeks after enrolment)
- Proportion of patients with at least one severe adverse event(within 24 weeks after enrolment)
研究者
研究点 (4)
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