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

Study Overview
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Brief Summary
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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).

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

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Triatec 10 mg
* Drug: Triatec HCT 5
* Drug: Lasix 25
* Drug: Micardis 80 mg
* Drug: Micardis plus 80/12.5
* Drug: Catapresan TTS 2
* Drug: Norvasc 10 mg
* Drug: Triatec 5 mg
* Drug: Pluscor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intensive Strategy<br> | Drug: Triatec 10 mg<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Triatec HCT 5<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Lasix 25<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Micardis 80 mg<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Micardis plus 80/12.5<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Catapresan TTS 2<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Norvasc 10 mg<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Triatec 5 mg<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Pluscor<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>|
| Other: Usual Strategy<br> | Drug: Triatec 10 mg<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Triatec HCT 5<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Lasix 25<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Micardis 80 mg<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Micardis plus 80/12.5<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Catapresan TTS 2<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Norvasc 10 mg<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Triatec 5 mg<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>Drug: Pluscor<br>* Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). |  | 0, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, systolic blood pressure