Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00421863
- Lead Sponsor
- Heart Care Foundation
- Brief Summary
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
Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1111
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive Strategy Micardis 80 mg - Usual Strategy Micardis 80 mg - Intensive Strategy Triatec 5 mg - Intensive Strategy Triatec HCT 5 - Usual Strategy Triatec HCT 5 - Intensive Strategy Norvasc 10 mg - Usual Strategy Norvasc 10 mg - Intensive Strategy Lasix 25 - Intensive Strategy Pluscor - Usual Strategy Triatec 10 mg - Usual Strategy Pluscor - Intensive Strategy Triatec 10 mg - Intensive Strategy Catapresan TTS 2 - Usual Strategy Triatec 5 mg - Intensive Strategy Micardis plus 80/12.5 - Usual Strategy Lasix 25 - Usual Strategy Micardis plus 80/12.5 - Usual Strategy Catapresan TTS 2 -
- Primary Outcome Measures
Name Time Method changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). 0, 12, 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Ospedale N. Melli
🇮🇹San Pietro Vernotico, Brindisi, Italy
Ospedale Civile Mellini
🇮🇹Chiari, BS, Italy
Ospedale Civile G. Chidichimo
🇮🇹Trebisacce, Cosenza, Italy
Istituto Neuromed
🇮🇹Pozzilli, Isernia, Italy
Presidio Ospedaliero F. Ferrari
🇮🇹Casarano, Lecce, Italy
Nuovo Ospedale Versilia
🇮🇹Lido di Camaiore, Lucca, Italy
Ospedale Civile
🇮🇹Ragusa, Italy
Ospedale Civile Beato Giacomo Villa
🇮🇹Città della Pieve, Perugia, Italy
Presidio Ospedaliero Città di Castello
🇮🇹Città di Castello, Perugia, Italy
Presidio Ospedaliero
🇮🇹Poggibonsi, Siena, Italy
Scroll for more (30 remaining)Ospedale N. Melli🇮🇹San Pietro Vernotico, Brindisi, Italy