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

February 2, 2021 updated by: Heart Care Foundation

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).

Study Overview

Status

Completed

Conditions

Hypertension

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

1111

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).
Other: 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).