Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,111
- 试验地点
- 40
- 主要终点
- changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG).
研究概览
简要总结
Multicenter, prospective, randomised, open study comparing the effect of the following two strategies in hypertensive subjects > 55 years and poorly controlled (systolic blood pressure >= 150 mmHg) by antihypertensive treatment:
- usual strategy: reduction of systolic blood pressure to below 140 mmHg, independently of diastolic blood pressure levels;
- intensive strategy: reduction of systolic blood pressure to below 130 mmHg, independently of diastolic blood pressure levels.
During the initial run in period two qualifying visits at distance of 7-14 days will be carried out to establish whether blood pressure remains uncontrolled (systolic blood pressure >=150 mmHg)by current drug treatment. At the end of the second visit eligible patients will be admitted to the study and the following examinations will be carried out: clinical visit, routine laboratory tests, 12-lead ECG. At this point eligible patients will be randomised to one of the two blood pressure goals outlined above.
Subsequent clinical visits will be carried out at 4 month-intervals up to the end of the study (4, 8, 12, 16, 20, 24 months).
详细描述
Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent to the study
- •age >= 55 years at randomization. There is no upper age limit
- •systolic blood pressure >= 150 mmHg in 2 visits at distance of 7-14 days, irrespective of diastolic pressure. Duration of treatment before visit 1 must be at least 12 weeks
- •at least one additional risk factor including the following:
- •current cigarette smoking
- •total cholesterol >= 20 mmg/dl, or High Density Lipoproteins (HDL) < 40 mg/dl, or Low Density Lipoproteins (LDL) cholesterol >= 130 mg/dl
- •family history of cardiovascular disease in male first degree relative < 55 years or female first degree relative < 65 years
- •previous TIA or stroke
- •previous coronary artery disease
- •history of peripheral occlusive arterial disease (claudication intermittens associated with angiographic or echographic evidence of > 60% stenosis)
排除标准
- •diabetes (fasting glucose > 125 mg/dl in two samples or ongoing diabetic treatment)
- •renal failure, defined by a serum creatinine > 2.0 mg/dl
- •chronic atrial fibrillation or flutter
- •clinically significant hepatic or hematological disorders, alcoholism, drug addiction
- •causes precluding ECG interpretation for LVH: complete right or left bundle block, Wolff-Parkinson-White syndrome, previous Q-wave myocardial infarction
- •any disease causing reduced life expectancy
- •unwilling to participate
- •significant (more than traces of) valvular heart disease
研究组 & 干预措施
Intensive Strategy
干预措施: Pluscor (Drug)
Usual Strategy
干预措施: Triatec 10 mg (Drug)
Intensive Strategy
干预措施: Triatec 10 mg (Drug)
Intensive Strategy
干预措施: Triatec HCT 5 (Drug)
Intensive Strategy
干预措施: Lasix 25 (Drug)
Intensive Strategy
干预措施: Micardis 80 mg (Drug)
Intensive Strategy
干预措施: Micardis plus 80/12.5 (Drug)
Intensive Strategy
干预措施: Catapresan TTS 2 (Drug)
Intensive Strategy
干预措施: Norvasc 10 mg (Drug)
Intensive Strategy
干预措施: Triatec 5 mg (Drug)
Usual Strategy
干预措施: Triatec HCT 5 (Drug)
Usual Strategy
干预措施: Lasix 25 (Drug)
Usual Strategy
干预措施: Micardis 80 mg (Drug)
Usual Strategy
干预措施: Micardis plus 80/12.5 (Drug)
Usual Strategy
干预措施: Catapresan TTS 2 (Drug)
Usual Strategy
干预措施: Norvasc 10 mg (Drug)
Usual Strategy
干预措施: Triatec 5 mg (Drug)
Usual Strategy
干预措施: Pluscor (Drug)
结局指标
主要结局
changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG).
时间窗: 0, 12, 24 months
次要结局
未报告次要终点