Lowering Blood Pressure in Primary Care in Vienna
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Achievement of the target office blood pressure (< 140/90 mmHg)
研究概览
简要总结
The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.
详细描述
Rationale Hypertension is the single largest contributor to mortality worldwide, accounting for 13% of deaths globally. Approximately 30% of the adult population suffer from hypertension and of those diagnosed and treated, only 30-50% have adequately controlled blood pressure. At present, the importance of hypertension as fundamental risk factors is inadequately addressed among many patients and physicians.
Design The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.
The trial will randomise 42 family doctors or resident specialists for internal medicine (enrolling 840 patients with treated or untreated hypertension) to either experimental care or standard care for hypertension, latter according to the 2013 European Society of Cardiology Guidelines for the Management of Arterial Hypertension.
Practitioners randomised to experimental care will up-titrate antihypertensive therapy with SPCs in 4-week intervals if the target blood pressure of < 140/90 mmHg is not reached at the respective follow-up (Figure 1).
Study Outcomes The primary efficacy endpoint will be the proportion of patients achieving the target office blood pressure after 6 months of follow-up. The main secondary endpoint will be the improvement of 24h ambulatory blood pressure (ABPM) profile, measured at inclusion and after 6 months of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •office blood pressure ≥ 140/90 mmHg
- •ACE inhibitor intolerance (experimental arm)
排除标准
- •Malignant disease with life expectancy < 6 months
- •Women of childbearing potential (ICH definition) or breastfeeding
- •Contraindications or allergies against olmesartan, amlodipine or hydrochlorothiazide (experimental arm)
- •Chronic kidney disease grade IV or V (eGFR < 30 ml/min)
- •Recent myocardial infarction or stroke within the preceding 3 months
- •Participation in another clinical trial
研究组 & 干预措施
Experimental Care
Treatment of hypertension using a standardised and simplified titration regime with single pill combinations, comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.
干预措施: Olmesartan medoxomil, amlodipine, hydrochlorothiazide (Drug)
结局指标
主要结局
Achievement of the target office blood pressure (< 140/90 mmHg)
时间窗: 6 months
Proportion of patients achieving the target office blood pressure of 140/90 mmHg
Achievement of the target systolic office blood pressure (< 140 mmHg)
时间窗: 6 months
Proportion of patients achieving the target systolic office blood pressure of 140 mmHg
Achievement of the target diastolic office blood pressure (< 90 mmHg)
时间窗: 6 months
Proportion of patients achieving the target diastolic office blood pressure of 90 mmHg
次要结局
- Achievement of the target average 24h systolic ambulatory blood pressure (< 130 mmHg)(6 months)
- Achievement of the target average daytime systolic ambulatory blood pressure (< 135 mmHg)(6 months)
- Achievement of the target average nighttime systolic ambulatory blood pressure (< 120 mmHg)(6 months)
- Achievement of the target average daytime diastolic ambulatory blood pressure (< 85 mmHg)(6 months)
- Achievement of the target average nighttime diastolic ambulatory blood pressure (< 70 mmHg)(6 months)
- Achievement of the target average 24h diastolic ambulatory blood pressure (< 80 mmHg)(6 months)
研究者
Thomas Weiss, MD, PhD
MD
Wilhelminenspital Vienna