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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:
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).
Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Strategy | Other |
| |
| Usual Strategy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triatec 10 mg | Drug | Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). | 0, 12, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Verdecchia, MD | Ospedale Silvestrini - Perugia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale N. Melli | San Pietro Vernotico | Brindisi | 72027 | Italy | ||
| Ospedale Civile Mellini |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18046432 | 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. | |
| 19683638 | Result | 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. |
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| Triatec HCT 5 | Drug | Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). |
|
| Lasix 25 | Drug | Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). |
|
| Micardis 80 mg | Drug | Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). |
|
| Micardis plus 80/12.5 | Drug | Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). |
|
| Catapresan TTS 2 | Drug | Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). |
|
| Norvasc 10 mg | Drug | Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). |
|
| Triatec 5 mg | Drug | Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). |
|
| Pluscor | Drug | Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy). |
|
| Chiari |
| BS |
| 25032 |
| Italy |
| Ospedale Civile G. Chidichimo | Trebisacce | Cosenza | 87075 | Italy |
| Istituto Neuromed | Pozzilli | Isernia | 86077 | Italy |
| Presidio Ospedaliero F. Ferrari | Casarano | Lecce | 73042 | Italy |
| Nuovo Ospedale Versilia | Lido di Camaiore | Lucca | 55043 | Italy |
| Ospedale Civile | Castiglione del Lago | Perugia | 06061 | Italy |
| Ospedale Civile Beato Giacomo Villa | Città della Pieve | Perugia | 06062 | Italy |
| Presidio Ospedaliero Città di Castello | Città di Castello | Perugia | 06012 | Italy |
| Ospedale Civile | Gubbio | Perugia | 06024 | Italy |
| Presidio Ospedaliero | Todi | Perugia | 06059 | Italy |
| Ospedale Silvestrini | Perugia | PG | Italy |
| Ospedale Civile | Sacile | Pordenone | 33077 | Italy |
| Ospedale Scillesi D'America | Scilla | Reggio Calabria | 89058 | Italy |
| Ospedale Civile | Thiesi | Sassari | 07047 | Italy |
| Presidio Ospedaliero | Poggibonsi | Siena | 53034 | Italy |
| Ospedale Civile S. Antonio Abate | Erice | Trapani | 91016 | Italy |
| Ospedale S. Antonio | San Daniele del Friuli | Udine | 33038 | Italy |
| Ospedale Generale Regionale | Aosta | 11100 | Italy |
| Azienda Ospedaliera G. Rummo | Benevento | 82100 | Italy |
| Spedali Civili | Brescia | 25123 | Italy |
| Azienda Ospedaliera G. Brotzu - S. Michele | Cagliari | 09134 | Italy |
| Ospedale S. Elia | Caltanissetta | 93100 | Italy |
| Ospedale Garibaldi-Nesima | Catania | 95122 | Italy |
| Azienda Ospedaliera Mater Domini | Catanzaro | 88100 | Italy |
| Ospedale Clinicizzato Santissima Annunziata | Chieti | 66013 | Italy |
| Istituti Ospitalieri | Cremona | 26100 | Italy |
| Dimi - Disem | Genova | 16132 | Italy |
| Ospedale Generale Provinciale | Gorizia | 34170 | Italy |
| Policlinico Universitario Federico II | Naples | 80131 | Italy |
| Azienda Ospedaliera di Perugia | Perugia | 06132 | Italy |
| Spedali Riuniti | Pistoia | 51100 | Italy |
| Ospedale Civile | Ragusa | 97100 | Italy |
| Ospedali Riuniti G. Melacrino F. Bianchi | Reggio Calabria | 89124 | Italy |
| Ospedale San Filippo Neri | Roma | 00135 | Italy |
| CTO | Roma | 00145 | Italy |
| Ospedlae San Camillo | Roma | 00149 | Italy |
| Ospedale San Camillo | Roma | 00152 | Italy |
| Ospedale San Giovanni | Roma | 00184 | Italy |
| Policlinico Universitario | Sassari | 07100 | Italy |
| Azienda Ospedaliera | Syracuse | 96100 | Italy |
| Azienda USL 4 Terni | Terni | 05100 | Italy |
| Ospedale San Vito | Torino | 10134 | Italy |
| Casa di Cura Villa Bianca | Trento | 38100 | Italy |
| Ospedale Belcolle | Viterbo | 01100 | Italy |
| 36398903 | Derived | 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. |
| 32905623 | Derived | 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. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017257 | Ramipril |
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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