In-Hospital Detection of Elevated Blood Pressure (INDEBP): Prevalence of New or Uncontrolled Hypertension and Safety of Postponement of Antihypertensive Treatment Adaption in Medical In-patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Prevalence of persisting new or uncontrolled arterial hypertension
研究概览
简要总结
The goal of this clinical trial is to analyse the prevalence of new or uncontrolled arterial hypertension (AHT) after hospital discharge of medical in-patients with elevated blood pressure (BP) values during hospitalisation.
The main questions it aims to answer are:
- Do elevated BP values during hospitalisation correspond to new or uncontrolled AHT after hospital discharge?
- Is it safe to postpone adaption of antihypertensive treatment until after proper evaluation of AHT after hospital discharge?
Participants will either be treated according to their physicians' decision or antihypertensive treatment adaptions will be postponed until after hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
In the first block, the treating physicians will not be informed about the study participation of their patient, in order to ensure that they will treat the patient according to what they perceive as the current usual practice. In the second block, the treating physicians will be informed about the study participation of their patients.
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
- •Patient hospitalized on the internal medicine ward for non-cardiovascular causes, i.e. patients hospitalized for conditions, which are not acutely worsened by uncontrolled AHT
- •Asymptomatic elevated BP values (defined as 140-180 mmHg systolic and/or 90-110 mmHg diastolic) on at least 2 occasions
- •Ability to understand study procedures and to provide written informed consent
排除标准
- •Hospitalization for any conditions which can be worsened by uncontrolled AHT:
- •Cerebrovascular events
- •Acute coronary syndrome
- •Acute or decompensated heart failure
- •Any condition preventing ABPM
- •Pregnant or lactating women
- •Failure to provide informed consent
结局指标
主要结局
Prevalence of persisting new or uncontrolled arterial hypertension
时间窗: 4 weeks after hospital discharge
Elevated blood pressure values in ambulatory blood pressure monitoring
Prevalence of a combined hypertensive complication endpoint
时间窗: Until 4 weeks after hospital discharge
Consisting of intracerebral bleeding, ischemic stroke, myocardial infarction, cardiovascular death or cardiovascular re-hospitalization
Prevalence of a combined hypotensive complication endpoint
时间窗: Until 4 weeks after hospital discharge
Consisting of falls, acute kidney injury, electrolyte disturbances, re-hospitalizations due to hypotension, or BP values on ABPM below the lower treatment limit
次要结局
- Prevalence of re-hospitalization for any cause(Until 4 weeks after hospital discharge)
- Clinic blood pressure measurement in mmHg(At baseline)
- Research blood pressure measurement in mmHg(At baseline)
- Prevalence of previously unknown arterial hypertension(At baseline)
- Prevalence of female gender(At baseline)
研究者
Annina Vischer
Principle Investigator
University Hospital, Basel, Switzerland