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

Sponsor:	Heart Care Foundation
Information provided by:	Heart Care Foundation
ClinicalTrials.gov Identifier:	NCT00421863

Purpose

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).

Condition	Intervention	Phase
Hypertension	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	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Ramipril Telmisartan Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by Heart Care Foundation:

Primary Outcome Measures:

changes in LVH at ECG. [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: Yes ]

Enrollment:	1111
Study Start Date:	February 2005
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intensive Strategy	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).
Usual Strategy: No Intervention	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

Assigned Interventions

Intensive Strategy

Drug: Triatec 10 mg