Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
NCT ID: NCT00421863
Last Updated: 2021-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1111 participants
INTERVENTIONAL
2005-02-28
2009-01-31
Brief Summary
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* 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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intensive Strategy
Triatec 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Triatec HCT 5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Lasix 25
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Micardis 80 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Micardis plus 80/12.5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Catapresan TTS 2
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Norvasc 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Triatec 5 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Pluscor
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Usual Strategy
Triatec 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Triatec HCT 5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Lasix 25
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Micardis 80 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Micardis plus 80/12.5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Catapresan TTS 2
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Norvasc 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Triatec 5 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Pluscor
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Interventions
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Triatec 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Triatec HCT 5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Lasix 25
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Micardis 80 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Micardis plus 80/12.5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Catapresan TTS 2
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Norvasc 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Triatec 5 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Pluscor
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
No
Sponsors
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Heart Care Foundation
OTHER
Responsible Party
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Principal Investigators
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Paolo Verdecchia, MD
Role: STUDY_CHAIR
Ospedale Silvestrini - Perugia
Locations
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Ospedale N. Melli
San Pietro Vernotico, Brindisi, Italy
Ospedale Civile Mellini
Chiari, BS, Italy
Ospedale Civile G. Chidichimo
Trebisacce, Cosenza, Italy
Istituto Neuromed
Pozzilli, Isernia, Italy
Presidio Ospedaliero F. Ferrari
Casarano, Lecce, Italy
Nuovo Ospedale Versilia
Lido di Camaiore, Lucca, Italy
Ospedale Civile
Castiglione del Lago, Perugia, Italy
Ospedale Civile Beato Giacomo Villa
Città della Pieve, Perugia, Italy
Presidio Ospedaliero Città di Castello
Città di Castello, Perugia, Italy
Ospedale Civile
Gubbio, Perugia, Italy
Presidio Ospedaliero
Todi, Perugia, Italy
Ospedale Silvestrini
Perugia, PG, Italy
Ospedale Civile
Sacile, Pordenone, Italy
Ospedale Scillesi D'America
Scilla, Reggio Calabria, Italy
Ospedale Civile
Thiesi, Sassari, Italy
Presidio Ospedaliero
Poggibonsi, Siena, Italy
Ospedale Civile S. Antonio Abate
Erice, Trapani, Italy
Ospedale S. Antonio
San Daniele del Friuli, Udine, Italy
Ospedale Generale Regionale
Aosta, , Italy
Azienda Ospedaliera G. Rummo
Benevento, , Italy
Spedali Civili
Brescia, , Italy
Azienda Ospedaliera G. Brotzu - S. Michele
Cagliari, , Italy
Ospedale S. Elia
Caltanissetta, , Italy
Ospedale Garibaldi-Nesima
Catania, , Italy
Azienda Ospedaliera Mater Domini
Catanzaro, , Italy
Ospedale Clinicizzato Santissima Annunziata
Chieti, , Italy
Istituti Ospitalieri
Cremona, , Italy
Dimi - Disem
Genova, , Italy
Ospedale Generale Provinciale
Gorizia, , Italy
Policlinico Universitario Federico II
Napoli, , Italy
Azienda Ospedaliera di Perugia
Perugia, , Italy
Spedali Riuniti
Pistoia, , Italy
Ospedale Civile
Ragusa, , Italy
Ospedali Riuniti G. Melacrino F. Bianchi
Reggio Calabria, , Italy
Ospedale San Filippo Neri
Roma, , Italy
CTO
Roma, , Italy
Ospedlae San Camillo
Roma, , Italy
Ospedale San Camillo
Roma, , Italy
Ospedale San Giovanni
Roma, , Italy
Policlinico Universitario
Sassari, , Italy
Azienda Ospedaliera
Syracuse, , Italy
Azienda USL 4 Terni
Terni, , Italy
Ospedale San Vito
Torino, , Italy
Casa di Cura Villa Bianca
Trento, , Italy
Ospedale Belcolle
Viterbo, , Italy
Countries
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References
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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.
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.
Other Identifiers
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C 33
Identifier Type: -
Identifier Source: org_study_id
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