Hypertension
Conditions
Keywords
hypertension, systolic blood pressure
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
Interventions
DRUGTriatec 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUGTriatec HCT 5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUGLasix 25
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUGMicardis 80 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUGMicardis plus 80/12.5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUGCatapresan TTS 2
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUGNorvasc 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUGTriatec 5 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUGPluscor
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Sponsors
Heart Care Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). | 0, 12, 24 months |
Countries
Italy
Outcome results
None listed