Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study


Phase 4 Results

Eligibility Criteria

Inclusion Criteria

- 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)

Exclusion Criteria

- 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