Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
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).