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

Heart Care Foundation

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Triatec 5 mg; Drug: Catapresan TTS 2; Drug: Triatec 10 mg; Drug: Micardis 80 mg; Drug: Pluscor; Drug: Lasix 25; Drug: Triatec HCT 5; Drug: Micardis plus 80/12.5; Drug: Norvasc 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00421863

C 33

Details and patient eligibility

About

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).

Full description

Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer

Enrollment: 1,111 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,111 participants in 2 patient groups

Intensive Strategy

Other group

Treatment:

Drug: Triatec 10 mg

Drug: Pluscor

Drug: Lasix 25

Drug: Triatec HCT 5

Drug: Micardis plus 80/12.5

Drug: Micardis 80 mg

Drug: Norvasc 10 mg

Drug: Triatec 5 mg

Drug: Catapresan TTS 2

Usual Strategy

Other group

Treatment:

Drug: Triatec 10 mg

Drug: Pluscor

Drug: Lasix 25

Drug: Triatec HCT 5

Drug: Micardis plus 80/12.5

Drug: Micardis 80 mg

Drug: Norvasc 10 mg

Drug: Triatec 5 mg

Drug: Catapresan TTS 2