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

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2009

Detailed Description

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

Interventions

  • 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

  • Other: Intensive Strategy
  • Other: Usual Strategy

Clinical Trial Outcome Measures

Primary Measures

  • changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG).
    • Time Frame: 0, 12, 24 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heart Care Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paolo Verdecchia, MD, Study Chair, Ospedale Silvestrini – Perugia

References

Cardio-Sis Study Group. Randomized study of traditional versus aggressive systolic blood pressure control (Cardio-Sis): rationale, design and characteristics of the study population. J Hum Hypertens. 2008 Apr;22(4):243-51. doi: 10.1038/sj.jhh.1002313. Epub 2007 Nov 29.

Citations Reporting on Results

Verdecchia P, Staessen JA, Angeli F, de Simone G, Achilli A, Ganau A, Mureddu G, Pede S, Maggioni AP, Lucci D, Reboldi G; Cardio-Sis investigators. Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial. Lancet. 2009 Aug 15;374(9689):525-33. doi: 10.1016/S0140-6736(09)61340-4. Erratum In: Lancet. 2009 Sep 12;374(9693):880.

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