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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heart Care Foundation
ClinicalTrials.gov Identifier:
NCT00421863
First received: January 12, 2007
Last updated: August 14, 2013
Last verified: March 2013

January 12, 2007
August 14, 2013
February 2005
January 2009   (final data collection date for primary outcome measure)
changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: Yes ]
changes in LVH at ECG.
Complete list of historical versions of study NCT00421863 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
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 partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hypertension
  • 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).
  • Intensive Strategy
    Interventions:
    • Drug: 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
  • Usual Strategy
    Interventions:
    • Drug: 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1111
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00421863
C 33
No
Heart Care Foundation
Heart Care Foundation
Not Provided
Study Chair: Paolo Verdecchia, MD Ospedale Silvestrini - Perugia
Heart Care Foundation
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP