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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heart Care Foundation
ClinicalTrials.gov Identifier:
NCT00421863
First received: January 12, 2007
Last updated: August 14, 2013
Last verified: March 2013
  Purpose

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).


Condition Intervention Phase
Hypertension
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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study

Resource links provided by NLM:


Further study details as provided by Heart Care Foundation:

Primary Outcome Measures:
  • changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). [ Time Frame: 0, 12, 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 1111
Study Start Date: February 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intensive Strategy Drug: Triatec 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Triatec HCT 5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Lasix 25
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Micardis 80 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Micardis plus 80/12.5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Catapresan TTS 2
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Norvasc 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Triatec 5 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Pluscor
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Usual Strategy Drug: Triatec 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Triatec HCT 5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Lasix 25
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Micardis 80 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Micardis plus 80/12.5
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Catapresan TTS 2
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Norvasc 10 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Triatec 5 mg
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
Drug: Pluscor
Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).

Detailed Description:

Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421863

Locations
Italy
Ospedale N. Melli
San Pietro Vernotico, Brindisi, Italy, 72027
Ospedale Civile Mellini
Chiari, BS, Italy, 25032
Ospedale Civile G. Chidichimo
Trebisacce, Cosenza, Italy, 87075
Istituto Neuromed
Pozzilli, Isernia, Italy, 86077
Presidio Ospedaliero F. Ferrari
Casarano, Lecce, Italy, 73042
Nuovo Ospedale Versilia
Lido di Camaiore, Lucca, Italy, 55043
Ospedale Civile
Castiglione del Lago, Perugia, Italy, 06061
Ospedale Civile Beato Giacomo Villa
Città della Pieve, Perugia, Italy, 06062
Presidio Ospedaliero Città di Castello
Città di Castello, Perugia, Italy, 06012
Ospedale Civile
Gubbio, Perugia, Italy, 06024
Presidio Ospedaliero
Todi, Perugia, Italy, 06059
Ospedale Silvestrini
Perugia, PG, Italy
Ospedale Civile
Sacile, Pordenone, Italy, 33077
Ospedale Scillesi D'America
Scilla, Reggio Calabria, Italy, 89058
Ospedale Civile
Thiesi, Sassari, Italy, 07047
Presidio Ospedaliero
Poggibonsi, Siena, Italy, 53034
Ospedale Civile S. Antonio Abate
Erice, Trapani, Italy, 91016
Ospedale S. Antonio
San Daniele del Friuli, Udine, Italy, 33038
Ospedale Generale Regionale
Aosta, Italy, 11100
Azienda Ospedaliera G. Rummo
Benevento, Italy, 82100
Spedali Civili
Brescia, Italy, 25123
Azienda Ospedaliera G. Brotzu - S. Michele
Cagliari, Italy, 09134
Ospedale S. Elia
Caltanissetta, Italy, 93100
Ospedale Garibaldi-Nesima
Catania, Italy, 95122
Azienda Ospedaliera Mater Domini
Catanzaro, Italy, 88100
Ospedale Clinicizzato Santissima Annunziata
Chieti, Italy, 66013
Istituti Ospitalieri
Cremona, Italy, 26100
Dimi - Disem
Genova, Italy, 16132
Ospedale Generale Provinciale
Gorizia, Italy, 34170
Policlinico Universitario Federico II
Napoli, Italy, 80131
Azienda Ospedaliera di Perugia
Perugia, Italy, 06132
Spedali Riuniti
Pistoia, Italy, 51100
Ospedale Civile
Ragusa, Italy, 97100
Ospedali Riuniti G. Melacrino F. Bianchi
Reggio Calabria, Italy, 89124
Ospedale San Filippo Neri
Roma, Italy, 00135
CTO
Roma, Italy, 00145
Ospedlae San Camillo
Roma, Italy, 00149
Ospedale San Giovanni
Roma, Italy, 00184
Ospedale San Camillo
Roma, Italy, 00152
Policlinico Universitario
Sassari, Italy, 07100
Azienda Ospedaliera
Siracusa, Italy, 96100
Azienda USL 4 Terni
Terni, Italy, 05100
Ospedale San Vito
Torino, Italy, 10134
Casa di Cura Villa Bianca
Trento, Italy, 38100
Ospedale Belcolle
Viterbo, Italy, 01100
Sponsors and Collaborators
Heart Care Foundation
Investigators
Study Chair: Paolo Verdecchia, MD Ospedale Silvestrini - Perugia
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heart Care Foundation
ClinicalTrials.gov Identifier: NCT00421863     History of Changes
Other Study ID Numbers: C 33
Study First Received: January 12, 2007
Last Updated: August 14, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Heart Care Foundation:
hypertension
systolic blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Clonidine
Amlodipine
Ramipril
Telmisartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014