HypertensionPhase 4NCT00421863
Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
A Phase 4 study testing Triatec 10 mg, Triatec HCT 5 and Lasix 25 in people with Hypertension, run by Heart Care Foundation at 45 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Triatec 10 mg, Triatec HCT 5 and Lasix 25
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,111 participants
- Where
- 45 sitesItaly
- Study dates
- Feb 2005to Jan 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
Italy45 sites
Ospedale Generale Regionale
Aosta, 11100
Azienda Ospedaliera G. Rummo
Benevento, 82100
Spedali Civili
Brescia, 25123
Azienda Ospedaliera G. Brotzu - S. Michele
Cagliari, 09134
Ospedale S. Elia
Caltanissetta, 93100
Presidio Ospedaliero F. Ferrari
Casarano, Lecce, 73042
Ospedale Civile
Castiglione del Lago, Perugia, 06061
Ospedale Garibaldi-Nesima
Catania, 95122
Azienda Ospedaliera Mater Domini
Catanzaro, 88100
Ospedale Civile Mellini
Chiari, BS, 25032
Ospedale Clinicizzato Santissima Annunziata
Chieti, 66013
Ospedale Civile Beato Giacomo Villa
Città della Pieve, Perugia, 06062
Presidio Ospedaliero Città di Castello
Città di Castello, Perugia, 06012
Istituti Ospitalieri
Cremona, 26100
Ospedale Civile S. Antonio Abate
Erice, Trapani, 91016
Dimi - Disem
Genova, 16132
Ospedale Generale Provinciale
Gorizia, 34170
Ospedale Civile
Gubbio, Perugia, 06024
Nuovo Ospedale Versilia
Lido di Camaiore, Lucca, 55043
Policlinico Universitario Federico II
Naples, 80131
Ospedale Silvestrini
Perugia, PG
Azienda Ospedaliera di Perugia
Perugia, 06132
Spedali Riuniti
Pistoia, 51100
Presidio Ospedaliero
Poggibonsi, Siena, 53034
Istituto Neuromed
Pozzilli, Isernia, 86077
Ospedale Civile
Ragusa, 97100
Ospedali Riuniti G. Melacrino F. Bianchi
Reggio Calabria, 89124
Ospedale San Filippo Neri
Roma, 00135
CTO
Roma, 00145
Ospedlae San Camillo
Roma, 00149
Ospedale San Camillo
Roma, 00152
Ospedale San Giovanni
Roma, 00184
Ospedale Civile
Sacile, Pordenone, 33077
Ospedale S. Antonio
San Daniele del Friuli, Udine, 33038
Ospedale N. Melli
San Pietro Vernotico, Brindisi, 72027
Policlinico Universitario
Sassari, 07100
Ospedale Scillesi D'America
Scilla, Reggio Calabria, 89058
Azienda Ospedaliera
Syracuse, 96100
Azienda USL 4 Terni
Terni, 05100
Ospedale Civile
Thiesi, Sassari, 07047
Presidio Ospedaliero
Todi, Perugia, 06059
Ospedale San Vito
Torino, 10134
Ospedale Civile G. Chidichimo
Trebisacce, Cosenza, 87075
Casa di Cura Villa Bianca
Trento, 38100
Ospedale Belcolle
Viterbo, 01100
About this study
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.
Read more
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).
Read the detailed description
Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer
- Conditions
- Hypertension
- Being tested
- Triatec 10 mg, Triatec HCT 5, Lasix 25, Micardis 80 mg, Micardis plus 80/12.5
- Keywords
- hypertension, systolic blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triatec 10 mgDrug
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Triatec HCT 5Drug
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Lasix 25Drug
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Micardis 80 mgDrug
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Micardis plus 80/12.5Drug
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Catapresan TTS 2Drug
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Norvasc 10 mgDrug
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Triatec 5 mgDrug
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
PluscorDrug
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
| Study group | Role | What they receive |
|---|---|---|
| Intensive Strategy | Other | Not described Receives: Drug: Triatec 10 mg; Drug: Triatec HCT 5; Drug: Lasix 25; Drug: Micardis 80 mg; Drug: Micardis plus 80/12.5; Drug: Catapresan TTS 2; Drug: Norvasc 10 mg; Drug: Triatec 5 mg; Drug: Pluscor |
| Usual Strategy | Other | Not described Receives: Drug: Triatec 10 mg; Drug: Triatec HCT 5; Drug: Lasix 25; Drug: Micardis 80 mg; Drug: Micardis plus 80/12.5; Drug: Catapresan TTS 2; Drug: Norvasc 10 mg; Drug: Triatec 5 mg; Drug: Pluscor |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG).
Measured: 0, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startFeb 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Care Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Verdecchia, MD, Study chair, Ospedale Silvestrini - Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421863
- Sponsor's protocol ID
- C 33
- Status last verified
- Mar 2013
- First submitted
- 12 Jan 2007
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18046432Verdecchia 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.
PubMed 19683638Saiz 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.
PubMed 36398903Saiz 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.
PubMed 32905623
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study
- ClinicalTrials.gov ID
- NCT00421863
- Acronym / sponsor ID
- C 33
- Conditions
- Hypertension
- Keywords
- hypertension, systolic blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,111 participants (actual)
- Lead sponsor
- Heart Care FoundationUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Strategy | Other | Drug: Triatec 10 mg, Drug: Triatec HCT 5, Drug: Lasix 25, Drug: Micardis 80 mg, Drug: Micardis plus 80/12.5, Drug: Catapresan TTS 2, Drug: Norvasc 10 mg, Drug: Triatec 5 mg, Drug: Pluscor |
| Usual Strategy | Other | Drug: Triatec 10 mg, Drug: Triatec HCT 5, Drug: Lasix 25, Drug: Micardis 80 mg, Drug: Micardis plus 80/12.5, Drug: Catapresan TTS 2, Drug: Norvasc 10 mg, Drug: Triatec 5 mg, Drug: Pluscor |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triatec 10 mgUse and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). | Drug | Intensive Strategy, Usual Strategy |
| Triatec HCT 5Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). | Drug | Intensive Strategy, Usual Strategy |
| Lasix 25Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). | Drug | Intensive Strategy, Usual Strategy |
| Micardis 80 mgUse and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). | Drug | Intensive Strategy, Usual Strategy |
| Micardis plus 80/12.5Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). | Drug | Intensive Strategy, Usual Strategy |
| Catapresan TTS 2Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). | Drug | Intensive Strategy, Usual Strategy |
| Norvasc 10 mgUse and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). | Drug | Intensive Strategy, Usual Strategy |
| Triatec 5 mgUse and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). | Drug | Intensive Strategy, Usual Strategy |
| PluscorUse and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). | Drug | Intensive Strategy, Usual Strategy |
Primary outcome
changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG).
Time frame: 0, 12, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 18046432Cardio-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 publication: PubMed 19683638Verdecchia 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.
- Derived from this study: PubMed 36398903Saiz 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.
- Derived from this study: PubMed 32905623Saiz 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.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Verdecchia, MD study chair
Ospedale Silvestrini - Perugia
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triatec 10 mg, Triatec HCT 5 and Lasix 25 in people with Hypertension, run by Heart Care Foundation at 45 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). (time frame: 0, 12, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00421863, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.