The Hypertension in the Very Elderly Trial (HYVET)
试验速览
- 阶段
- 4 期
- 入组人数
- 4,000
- 试验地点
- 14
- 主要终点
- All strokes (fatal and non-fatal)
研究概览
简要总结
The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.
详细描述
The benefit to risk ratio of treating hypertensives aged 80 or older has not been established. It has been suggested that at this age for each stroke prevented there is one non-stroke death. HYVET is designed to help clarify this.
HYVET is a randomised, double-blind, placebo-controlled trial in hypertensive subjects aged 80 or older. Active treatment consists of indapamide 1.5mg SR with the addition of perindopril 2mg - 4mg to reach a target blood pressure (BP) of <150/80 mmHg. Entry criteria include a systolic blood pressure of 160-199 mmHg. Patients with isolated systolic hypertension (ISH) have been recruited since August 2003.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 80 or older
- •Sitting systolic BP 160-199 mmHg AND sitting diastolic BP < 110 mmHg
排除标准
- •Known accelerated hypertension (retinal haemorrhages or exudates or papilloedema).
- •Overt clinical congestive heart failure requiring treatment with a diuretic or angiotensin converting enzyme inhibitor. Subjects allowed if treated with digoxin only.
- •Renal failure (serum creatinine of more than 150 µmol/l).
- •Previous documented cerebral or subarachnoid haemorrhage in the last 6 months. (Ischaemic cerebral and cardiac events do not exclude, although the patient must be neurologically and cardiologically stable.)
- •Condition expected to severely limit survival, e.g. terminal illness.
- •Known secondary hypertension (e.g. renal artery stenosis, chronic renal insufficiency, and endocrine cause).
- •Clinical diagnosis of dementia.
- •Resident in a nursing home, i.e. where the dependency and care requirements of the patients are such that they require the regular input of qualified nurses and therefore the majority of staff in the home are nurses (other forms of residential care are acceptable).
- •Unable to stand up or walk
- •Participation in a drug trial within the past month preceding selection.
- •Alcohol or drug abuse.
- •Less than 2 months placebo run-in.
- •Contraindications to use of trial drugs
结局指标
主要结局
All strokes (fatal and non-fatal)
时间窗: Duration of trial
次要结局
- Stroke mortality(Duration of Trial)
- Fracture rates(Duration of trial)
- Cardiac mortality(Duration of trial)
- Total mortality(duration of trial)
- Cardiovascular mortality(Duration of trial)