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

Completed

Phase 4 Results

Trial Description

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

Conditions

Interventions

  • Telmisartan (Micardis® )Drug
    Intervention Desc: Telmisartan is used alone or in combination with other medications to treat high blood pressure. Telmisartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain chemicals that tighten the blood vessels, so blood flows more smoothly.
  • Ramipril (Altace®)Drug
    Intervention Desc: Ramipril is used alone or in combination with other medications to treat high blood pressure. It is also used to reduce the risk of heart attack and stroke in patients at risk for these problems and to improve survival in patients with heart failure after a heart attack. Ramipril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly and the heart can pump blood more efficiently.
  • Clonidine Drug
    Intervention Desc: Clonidine is a direct-acting α2 adrenergic agonist prescribed historically as an antihypertensive agent.
  • Amlodipine Drug
    Intervention Desc: is a long-acting calcium channel blocker (dihydropyridine class) used as an anti-hypertensive and in the treatment of angina.
  • Lasix (furosemide )Other
    Intervention Desc: Lasix is a loop diuretic (water pill) that prevents your body from absorbing too much salt, allowing the salt to instead be passed in your urine.
  • Pluscor Drug
    Intervention Desc: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
    ARM 1: Kind: Experimental
    Label: Intensive Strategy
    ARM 2: Kind: Experimental
    Label: Usual Strategy
  • Triatec HCT (Ramipril and hydrochlorothiazide)Drug
    Intervention Desc: ACE Inhibitor Combinations with Antihypertensives and/or Diuretics
  • Triatec 10 mg Drug
    Intervention Desc: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
    ARM 1: Kind: Experimental
    Label: Intensive Strategy
    ARM 2: Kind: Experimental
    Label: Usual Strategy
  • Triatec HCT 5 Drug
    Intervention Desc: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
    ARM 1: Kind: Experimental
    Label: Intensive Strategy
    ARM 2: Kind: Experimental
    Label: Usual Strategy
  • Lasix 25 Drug
    Intervention Desc: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
    ARM 1: Kind: Experimental
    Label: Intensive Strategy
    ARM 2: Kind: Experimental
    Label: Usual Strategy
  • Micardis 80 mg Drug
    Intervention Desc: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
    ARM 1: Kind: Experimental
    Label: Intensive Strategy
    ARM 2: Kind: Experimental
    Label: Usual Strategy
  • Micardis plus 80/12.5 Drug
    Intervention Desc: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
    ARM 1: Kind: Experimental
    Label: Intensive Strategy
    ARM 2: Kind: Experimental
    Label: Usual Strategy
  • Catapresan TTS 2 Drug
    Intervention Desc: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
    ARM 1: Kind: Experimental
    Label: Intensive Strategy
    ARM 2: Kind: Experimental
    Label: Usual Strategy
  • Norvasc 10 mg Drug
    Intervention Desc: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
    ARM 1: Kind: Experimental
    Label: Intensive Strategy
    ARM 2: Kind: Experimental
    Label: Usual Strategy
  • Triatec 5 mg Drug
    Intervention Desc: Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
    ARM 1: Kind: Experimental
    Label: Intensive Strategy
    ARM 2: Kind: Experimental
    Label: Usual Strategy

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms: ARM 1 usual strategy: reduction of systolic blood pressure to below 140 mmHg, independently of diastolic blood pressure levels; or Arm 2 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). Use and dosage of antihypertensive drugs according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes in LVH at ECG.
Primary changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). 0, 12, 24 months Yes

Sponsors