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

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).

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2009

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

Intervention(s) in this Clinical Trial

• Drug: Triatec 10 mg
  • Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
• Drug: Triatec HCT 5
  • Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
• Drug: Lasix 25
  • Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
• Drug: Micardis 80 mg
  • Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
• Drug: Micardis plus 80/12.5
  • Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
• Drug: Catapresan TTS 2
  • Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
• Drug: Norvasc 10 mg
  • Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
• Drug: Triatec 5 mg
  • Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
• Drug: Pluscor
  • Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).

Arms, Groups and Cohorts in this Clinical Trial

• Other: Intensive Strategy
• No Intervention: Usual Strategy

Primary Measures

• changes in LVH at ECG.
  • Time Frame: 0, 12, 24 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Heart Care Foundation

Overall Clinical Trial Officials and Contacts

Paolo Verdecchia, MD Study Chair Ospedale Silvestrini - Perugia  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00421863

Study ID Number: C 33

ClinicalTrials.gov Identifier: NCT00421863

Health Authority: Italy: Ministry of Health