Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
Information source: Heart Care Foundation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: 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 (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Heart Care Foundation Official(s) and/or principal investigator(s):
Paolo Verdecchia, MD, Study Chair, Affiliation: Ospedale Silvestrini - Perugia
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).
Clinical Details
Official title: Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: changes in LVH at ECG.
Detailed description:
Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
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 HDL < 40 mg/dl, or 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 (claudicatio 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
Locations and Contacts
Ospedale San Vito, Torino 10134, Italy
Ospedale Generale Regionale, Aosta 11100, Italy
Spedali Civili, Brescia 25123, Italy
Ospedale Silvestrini, Perugia, PG, Italy
Additional Information
Starting date: February 2005
Last updated: September 24, 2007
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