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NCT Number: NCT00421863

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

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale Civile Mellini, Chiari, BS, Italy

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triatec 10 mg

Drug

Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).

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).

Primary outcomes

  1. changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG).

    Time frame: 0, 12, 24 months

Sponsors and collaborators

Lead sponsor

Heart Care Foundation

Other

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jan 15, 2007
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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