Status:
COMPLETED
Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
Lead Sponsor:
Heart Care Foundation
Conditions:
Hypertension
Eligibility:
All Genders
55+ years
Phase:
PHASE4
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) ...
Detailed Description
Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
1111 Patients enrolled
Trial Details
Trial ID
NCT00421863
Start Date
February 1 2005
End Date
January 1 2009
Last Update
February 3 2021
Active Locations (45)
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1
Ospedale N. Melli
San Pietro Vernotico, Brindisi, Italy, 72027
2
Ospedale Civile Mellini
Chiari, BS, Italy, 25032
3
Ospedale Civile G. Chidichimo
Trebisacce, Cosenza, Italy, 87075
4
Istituto Neuromed
Pozzilli, Isernia, Italy, 86077