Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in 24-hour ambulatory mean systolic daytime blood pressure
研究概览
简要总结
The purpose of the study is to access the change in mean daytime systolic blood pressure in participants with essential hypertension not adequately controlled (defined as mean systolic daytime ambulatory blood pressure ≥ 135 mmHg) and randomly assigned to either an intervention group with one-time only Direct Observed Therapy (DOT) immediately followed by ABPM or a control group with standard ABPM.
详细描述
More than 1 billion people world wide suffer from hypertension (HT), leaving it the world´s top rank risk factor and contributor to global disease burden. Cardiac disease, stroke, kidney disease and dementia are diseases related to HT with high economic burden on societies and each year 9.4 million people die as a direct consequence of HT.
Estimated < 50 % of hypertensive patients adhere to preventive hypertensive medication after 1 year of treatment.
Poor adherence to antihypertensive treatment have by many been explained partly by the silent nature of hypertension, the risk of side effects from antihypertensive medication, treatment expenditures and the patient health perspectives.
In a randomized controlled trial design we plan to enrol 20 subjects, the limited number explained by the study being part of the initial planning of a larger scale trial organized by the research group, to invistigate the change in ambulatory bloodpressure with or with out Direct Observed Theraphy prior to meassurement, as a one-time-only medication adherence check.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •18 years and above
- •Residing in Oslo/Akershus
- •Ambulatory Systolic Daytime Blood Pressure ≥ 135 mmHg
- •≥ 2 antihypertensive medications
- •Be able to read and write Norwegian
排除标准
- •Critical illness, ongoing treatment
- •Known atrial fibrillation
- •Known heart valve stenosis
- •Myocardial infarction, angina pectoris or stroke the past 6 months
- •Known severe renal impairment (eGFR < 30 ml/min/1.73 m2)
- •History of DOT prior to ABPM
- •Participation in other interventional study
研究组 & 干预措施
Direct Observed Therapy
Direct Observed Therapy immediately followed by mounting of ambulatory blood pressure device and measurement of ambulatory blood pressure according to ESH 2013 guidelines.
干预措施: Direct Observed Therapy (Other)
Control
Standard care
结局指标
主要结局
Change in 24-hour ambulatory mean systolic daytime blood pressure
时间窗: Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.
次要结局
- Change in mean office systolic blood pressure(Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.)
研究者
Ulla Hjørnholm
RN MSc
Oslo University Hospital