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

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).

Timeline

Start

2005-02

Primary completion

2009-01

Completion

2009-01

Publications

• Background Cardio-Sis Study Group. Randomized study of traditional versus aggressive systolic blood pressure control (Cardio-Sis): rationale, design and characteristics of the study population. J Hum Hypertens. 2008 Apr;22(4):243-51. doi: 10.1038/sj.jhh.1002313. Epub 2007 Nov 29.
• Results Verdecchia P, Staessen JA, Angeli F, de Simone G, Achilli A, Ganau A, Mureddu G, Pede S, Maggioni AP, Lucci D, Reboldi G; Cardio-Sis investigators. Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial. Lancet. 2009 Aug 15;374(9689):525-33. doi: 10.1016/S0140-6736(09)61340-4.
• Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
• Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.

Drugs

Indications