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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00421863
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Heart Care Foundation

Tracking Information
First Submitted Date  ICMJE January 12, 2007
First Posted Date  ICMJE January 15, 2007
Last Update Posted Date August 15, 2013
Study Start Date  ICMJE February 2005
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2013)
changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). [ Time Frame: 0, 12, 24 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2007)
changes in LVH at ECG.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
Official Title  ICMJE Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
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) 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).

Detailed Description Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2008)
1111
Original Enrollment  ICMJE
 (submitted: January 12, 2007)
1100
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00421863
Other Study ID Numbers  ICMJE C 33
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heart Care Foundation
Study Sponsor  ICMJE Heart Care Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Paolo Verdecchia, MD Ospedale Silvestrini - Perugia
PRS Account Heart Care Foundation
Verification Date March 2013

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