ISRCTN04503926Completed未知
Effect of valsartan on endothelial function, carotid intima-media thickness, left ventricular mass, arterial compliance, inflammation and coagulation abnormalities in the metabolic syndrome
Central Manchester and Manchester Children's Hospitals NHS Trust (UK)0 sites120 target enrollmentStarted: February 7, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Individuals with metabolic syndrome without diabetes
- •2. Male or female at least 18 years and less than 80 years
- •3. Provision of signed informed consent form
- •4. Females of child-bearing potential (i.e., females who are not chemically or surgically sterilised or females who are not post-menopause) must have a negative urine or blood pregnancy test at enrolment and be willing to use two methods of reliable contraception, one of which must be a barrier method
Exclusion Criteria
- •1. Prior history of overt coronary artery disease, cardiac failure, peripheral vascular disease, cerebrovascular disease or diabetes
- •2. History of significant renal or hepatic disease
- •3. Pregnant or lactating women
- •4. Severe hypertension (blood pressure [BP] greater than 180/110 mmHg)
- •5. Current antihypertensive treatment
- •6. Current drug therapy directly acting on the renin-angiotensin-aldosterone system
- •7. Chronic anaemia (haemoglobin less than 10 g/L)
- •8. Inadequate carotid ultrasonographic/echocardiographic images
- •9. Excessive alcohol consumption
- •10. Significant valvular disease
- •11. History of primary myocardial disease, e.g. dilated cardiomyopathy, viral myocarditis, hypertrophic cardiomyopathy
- •12. Previous enrolment or randomisation of treatment in the present study
- •13. Participation in another investigational drug/interventional study in the last 30 days
Investigators
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