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This trial is included in the following systematic reviews and meta-analyses:
Related trials
See also:
Cardio-Sis study, 2009 |
|
| [NCT00421863] | |
Treatments
| Studied treatment |
tighter control of systolic BP with a goal of <130 mm Hg
One SBP measure higher than 130 mm Hg at any visit led to intensification of treatment. The choice of drugs in individual patients was left to the discretion of the investigators |
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| Control treatment |
usual control, with a goal of <140 mm Hg
achievement of an SBP <130 mm Hg entailed down-titration of treatment. The choice of drugs in individual patients was left to the discretion of the investigators |
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| Treatments description |
|
Patients
| Patients | nondiabetic patients with hypertension and with SBP of 150 mm Hg or higher confirmed at two different times | ||||||||
| Inclusion criteria | age >=55 years; SBP >150 mm Hg; antihypertensive treatment for at least 12 weeks; at least one of the following risk factors: smoking, family history of premature CAD, established CAD/PAD, previous TIA/stroke, total cholesterol >201 mg/dl, high-density lipoprotein cholesterol <39 mg/dl, low-density lipoprotein cholesterol >135 mg/dl | ||||||||
| Exclusion criteria | fasting glucose >126 mg/dl; reduced life expectancy; renal dysfunction (creatinine >2 mg/dl); clinically relevant hematologic or hepatic disorders; valvular heart disease; disorders associated with a confusion in the ECG diagnosis of LVH (complete right/left bundle branch block, Wolff-Parkinson-White syndrome, previous Q-wave MI, paced rhythm); AF; substance abuse | ||||||||
| Baseline characteristics |
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Method and design
| Randomized effectives | 558 / 553 (studied vs. control) |
| Design | Parallel groups |
| Blinding | open |
| Follow-up duration | 2 years |
| Number of centre | 44 |
| Geographic area | Italy |
| Hypothesis | Superiority |
| Primary endpoint | ECG evidence of LVH |
Results
n/N
n/N
myocardial infarction (fatal and non fatal)
Heart failure
left ventricular hypertrophy
All cause death
stroke (fatal and non fatal)
Major cardiovascular events
| Relative risks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Endpoint | Events (%) | Relative Risk | 95% CI | Endpoint definition in the trial |
Ref | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Studied treat. | Control treat. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| myocardial infarction (fatal and non fatal) | 4 / 558 (0,7%) | 6 / 553 (1,1%) | 0,66 | [0,19;2,33] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| stroke (fatal and non fatal) | 4 / 558 (0,7%) | 9 / 553 (1,6%) | 0,44 | [0,14;1,42] | strok eor TIA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Major cardiovascular events | 17 / 558 (3,0%) | 32 / 553 (5,8%) | 0,53 | [0,30;0,94] | death, MI, stroke, HF, angina, revascularization | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| left ventricular hypertrophy | 55 / 484 (11,4%) | 82 / 483 (17,0%) | 0,67 | [0,49;0,92] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| All cause death | 4 / 558 (0,7%) | 5 / 553 (0,9%) | 0,79 | [0,21;2,94] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Heart failure | 3 / 558 (0,5%) | 7 / 553 (1,3%) | 0,42 | [0,11;1,63] | admission for HF | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| The primary endpoint (if exists) appears in blod characters | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Reference(s) used for data extraction: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Absolute risk reduction | ||||
| Endpoint | Events rate | Absolute risk reduction (ARR) |
||
|---|---|---|---|---|
| Studied treat. | Control treat. | |||
| myocardial infarction (fatal and non fatal) | 7,17‰ | 1,08% | -3,7‰ | |
| stroke (fatal and non fatal) | 7,17‰ | 1,63% | -9,1‰ | |
| Major cardiovascular events | 3,05% | 5,79% | -27,4‰ | |
| left ventricular hypertrophy | 11,36% | 16,98% | -56,1‰ | |
| All cause death | 7,17‰ | 9,04‰ | -1,9‰ | |
| Heart failure | 5,38‰ | 1,27% | -7,3‰ | |
Reference(s)
| Trials register # | NCT00421863 |
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Verdecchia P, Staessen JA, Angeli F, de Simone G, Achilli A, Ganau A, Mureddu G, Pede S, Maggioni AP, Lucci D, Reboldi G.
Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial..
Lancet 2009;374:525-33
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