Clinical trial NCT00421863: Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
Official title: Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension
systolic blood pressure
Lead sponsor: Heart Care Foundation
Sponsor class: OTHER
First posted: 2007-01-15
Enrollment: 1111
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG).
timeFrame: 0, 12, 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Pietro Vernotico
country: Italy
facility: Ospedale N. Melli
state: Brindisi
city: Chiari
country: Italy
facility: Ospedale Civile Mellini
state: BS
city: Trebisacce
country: Italy
facility: Ospedale Civile G. Chidichimo
state: Cosenza
city: Pozzilli
country: Italy
facility: Istituto Neuromed
state: Isernia
city: Casarano
country: Italy
facility: Presidio Ospedaliero F. Ferrari
state: Lecce
city: Lido di Camaiore
country: Italy
facility: Nuovo Ospedale Versilia
state: Lucca
city: Castiglione del Lago
country: Italy
facility: Ospedale Civile
state: Perugia
city: Città della Pieve
country: Italy
facility: Ospedale Civile Beato Giacomo Villa
state: Perugia
city: Città di Castello
country: Italy
facility: Presidio Ospedaliero Città di Castello
state: Perugia
city: Gubbio
country: Italy
facility: Ospedale Civile
state: Perugia
city: Todi
country: Italy
facility: Presidio Ospedaliero
state: Perugia
city: Perugia
country: Italy
facility: Ospedale Silvestrini
state: PG
city: Sacile
country: Italy
facility: Ospedale Civile
state: Pordenone
city: Scilla
country: Italy
facility: Ospedale Scillesi D'America
state: Reggio Calabria
city: Thiesi
country: Italy
facility: Ospedale Civile
state: Sassari
city: Poggibonsi
country: Italy
facility: Presidio Ospedaliero
state: Siena
city: Erice
country: Italy
facility: Ospedale Civile S. Antonio Abate
state: Trapani
city: San Daniele del Friuli
country: Italy
facility: Ospedale S. Antonio
state: Udine
city: Aosta
country: Italy
facility: Ospedale Generale Regionale
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo
city: Brescia
country: Italy
facility: Spedali Civili
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu - S. Michele
city: Caltanissetta
country: Italy
facility: Ospedale S. Elia
city: Catania
country: Italy
facility: Ospedale Garibaldi-Nesima
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini
city: Chieti
country: Italy
facility: Ospedale Clinicizzato Santissima Annunziata
city: Cremona
country: Italy
facility: Istituti Ospitalieri
city: Genova
country: Italy
facility: Dimi - Disem
city: Gorizia
country: Italy
facility: Ospedale Generale Provinciale
city: Napoli
country: Italy
facility: Policlinico Universitario Federico II
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia
city: Pistoia
country: Italy
facility: Spedali Riuniti
city: Ragusa
country: Italy
facility: Ospedale Civile
city: Reggio Calabria
country: Italy
facility: Ospedali Riuniti G. Melacrino F. Bianchi
city: Roma
country: Italy
facility: Ospedale San Filippo Neri
city: Roma
country: Italy
facility: CTO
city: Roma
country: Italy
facility: Ospedlae San Camillo
city: Roma
country: Italy
facility: Ospedale San Camillo
city: Roma
country: Italy
facility: Ospedale San Giovanni
city: Sassari
country: Italy
facility: Policlinico Universitario
city: Siracusa
country: Italy
facility: Azienda Ospedaliera
city: Terni
country: Italy
facility: Azienda USL 4 Terni
city: Torino
country: Italy
facility: Ospedale San Vito
city: Trento
country: Italy
facility: Casa di Cura Villa Bianca
city: Viterbo
country: Italy
facility: Ospedale Belcolle
Study officials:
affiliation: Ospedale Silvestrini - Perugia
name: Paolo Verdecchia, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.