Cardiovascular Risk Evaluation in Clinical Practice in Metabolic Syndrome Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171548
First received: September 12, 2005
Last updated: September 19, 2008
Last verified: September 2008
  Purpose

Metabolic syndrome is commonly defined as a set of risk factors and abnormalities that markedly increase the risk of cardiovascular events. Its relevance has been confirmed by a recent population-based survey of subjects aged 40-79 years indicating that the prevalence of metabolic syndrome in Italy is 34.1% if diagnosed using WHO criteria and 17.8% if diagnosed using the NCEP-ATPIII criteria.

On the basis of the above considerations, the aim of this study is to promote the use of the SCORE algorithm for estimating cardiovascular risk, and to evaluate its evolution in patients with metabolic syndrome after the implementation of a multifactorial preventive strategy, with particular reference to the correction of lifestyle, hypertension and dyslipidemia.


Condition Phase
Metabolic Syndrome
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Project to Promote the Evaluation of Cardiovascular Risk in Clinical Practice, and Assess Its Evolution After the Implementation of Multifactorial Preventive Strategy Aimed at Reducing the Level of Global Risk (SCORE Algorithm) in Subjects With Metabolic Syndrome and a Risk Level of 5%

Resource links provided by NLM:


Further study details as provided by Novartis:

Enrollment: 600
Study Start Date: October 2004
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Patients of both genders aged 40-65 years.
  • A diagnosis of metabolic syndrome formulated on the basis of the criteria proposed by the NCEP - Adult Panel III: i.e. the presence of at least three of the following conditions:

    1. Waist circumference >102 cm in men and >88 cm in women
    2. Triglyceridemia 150 mg/dl
    3. HDL cholesterol <40 mg/dl in men and <50 mg/dl in women
    4. Sitting arterial pressure 130/85 mmHg
    5. Fasting glycemia 110 mg/dl
  • A risk of cardiovascular death of >5% at the current age of the patient or >5% if projected to an age of 60 years, as calculated by means of the SCORE algorithm using the table based on the total/HDL cholesterol ratio relating to low-risk populations and appropriate for Italy.
  • Written informed consent.

Exclusion Criteria:

  • Women who have not been in menopause for at least one year or are not surgically sterile, and do not use an effective contraceptive method, such as spermicidal barrier methods or intrauterine devices. The use of oral contraceptives is not allowed.
  • Known or suspected hypersensitivity to valsartan and/or fluvastatin, or other contraindications to their use;
  • A positive history of ischemic heart disease, peripheral artery disease or cerebral vasculopathy;
  • Patients with an SBP of 180 mmHg and/or DBP of 110 mmHg.
  • Patients with severe medical conditions which, in the judgement of the Investigator, contraindicate trial participation or significantly limit life expectancy;
  • Treatment with drugs able to modify the lipid profile (ongoing or in the three months preceding trial entry);
  • Patients unable to follow the planned protocol procedures or sign the informed consent form.
  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: NCT00171548

Locations
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00171548     History of Changes
Other Study ID Numbers: CVAL489AIT05
Study First Received: September 12, 2005
Last Updated: September 19, 2008
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Novartis:
Metabolic syndrome, cardiovascular risk reduction

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014