Treatment of HYpertension: Morning Versus Evening
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Average nocturnal blood pressure, percentage dipping and nadir of nocturnal blood pressure
研究概览
简要总结
Rationale:
The nocturnal blood pressure mean is an independent and stronger predictor of cardiovascular disease (CVD) risk than either daytime office, awake or 24hour mean blood pressure. In general, when nocturnal blood pressure does not decline CVD risk is higher, usually referred to as "dippers" versus "non-dippers". Evening administration of treatment might lower nocturnal blood pressure more effectively than morning administration, which is most commonly advised.
The main hypothesis of this study is that evening administration of antihypertensive medication might resume the dipping pattern in non-dippers and as a consequence might reduce CVD risk more than morning administration.
Primary objective (in short):
-to prove that evening administration of enalapril/hydrochlorothiazide in non-dippers can resume a dipping blood pressure pattern in non-dippers
Study design: A double-blind placebo-controlled cross-over study Each person will use for one period of six weeks enalapril/hydrochlorothiazide in the morning and placebo in the evening, and one period of six weeks the other way around
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Essential hypertension
- •Stable blood pressure on treatment with Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin II Receptor Blocker (ARB) and hydrochlorothiazide
- •Age between 18 and 85 years
- •WHO performance status 0-1
- •Available for a time period of 15 weeks
- •Written informed consent
- •Dippers: Nocturnal blood pressure fall of 10-20% of daytime values.20
- •Non-dippers: -Nocturnal blood pressure fall of <10% of daytime values
排除标准
- •secondary cause of hypertension
- •use of ARB because of intolerability (e.g. dry cough) of ACEI
- •nocturnal blood pressure fall of >20% or rise
- •renal insufficiency (GFR<60 ml/min)
- •shift work
- •pregnancy or wish to get pregnant
- •use of other antihypertensive medication than ACEI, ARB, hydrochlorothiazide or a calcium channel blocker
- •use of sleeping medication
研究组 & 干预措施
Enalapril/hydrochlorothiazide
This arm will start with six weeks of administration of enalapril/hydrochlorothiazide in the evening and placebo in the morning, followed by six weeks of active treatment in the morning and placebo in the evening
干预措施: Placebo (Drug)
Enalapril/hydrochlorothiazide
This arm will start with six weeks of administration of enalapril/hydrochlorothiazide in the evening and placebo in the morning, followed by six weeks of active treatment in the morning and placebo in the evening
干预措施: Enalapril/hydrochlorothiazide (Drug)
Placebo
This arm will start with six weeks of morning administration of enalapril/hydrochlorothiazide in the morning and placebo in the evening, followed by six weeks of placebo in the morning and active treatment in the evening
干预措施: Enalapril/hydrochlorothiazide (Drug)
Placebo
This arm will start with six weeks of morning administration of enalapril/hydrochlorothiazide in the morning and placebo in the evening, followed by six weeks of placebo in the morning and active treatment in the evening
干预措施: Placebo (Drug)
结局指标
主要结局
Average nocturnal blood pressure, percentage dipping and nadir of nocturnal blood pressure
时间窗: 24 hours
At the end of each treatment period of six weeks, a 24 hour ambulatory blood pressure measurement will be performed
次要结局
- Plasma: enalapril, cortisol, melatonin, aldosterone, ACE activity, gene expression of clock genes(Moring of 24 hour blood pressure measurement after six weeks of treatment according to a certain regime)
- Percentage of nocturnal diastolic blood pressure measurements below 65 mm hg(24 hours)
- Urine: Sodium, potassium, protein, melatonin, creatinin(Two times within 24 hours at the end of six weeks of treatment according to one of the two regimes)
研究者
Jorie Versmissen
MD, PhD
Erasmus Medical Center