Status:

COMPLETED

Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Prevention of Cardiovascular Disease

Lead Sponsor:

National Research Council, Spain

Collaborating Sponsors:

Hospital General Universitario Morales Meseguer

Conditions:

Cardiovascular Diseases

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief Summary

Resveratrol can exhibit benefits against cardiovascular diseases (CVDs) although the cardioprotective role of resveratrol as part of the human diet is not yet clear. The aim of this trial is to evalu...

Eligibility Criteria

Inclusion

  • FOR PRIMARY PREVENTION:
  • Lack of known cardiovascular disease (coronary acute syndrome, stable ischemic cardiopathy, peripheric arteriopathy and cerebrovascular diseases).
  • Age between 18 and 80 years.
  • The above criteria and diabetes mellitus or at least two of the following risk factors:
  • Active smoking (10 cigarettes or more per day).
  • Arterial hypertension (\>= 140/90 mmHg).
  • Hypercholesterolemia (LDL-cholesterol \>130 mg/dL and/or HDL-cholesterol \< 45 mg/dL in women and 50 mg/dL in men).
  • Obesity (BMI \> 30 kg/m2)
  • FOR SECONDARY PREVENTION:
  • Stable patients who coronary syndrome, cerebrovascular accident or peripheric arteriopathy event occurred at least 6 months or more before the recruitment in the study. In addition:
  • Age between 18 and 80 years.
  • Ejection fraction of left ventricle \>=45%.
  • Functional status I or II according to the New York Heart Association.
  • Clinic stability in the recruitment (no symptoms of thoracic pain during the last month).
  • Lack of residual lesions without vascularization in those patients with catheterism.

Exclusion

  • FOR PRIMARY AND SECONDARY PREVENTION:
  • Patients who do not satisfy inclusion criteria and:
  • Known allergy to grapes
  • Pregnancy or lactation
  • Intake of nutraceuticals

Key Trial Info

Start Date :

April 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2011

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT01449110

Start Date

April 1 2009

End Date

March 1 2011

Last Update

November 16 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University Hospital Morales Meseguer

Murcia, Spain, 30008