Effect of valsartan on endothelial function, carotid intima-media thickness, left ventricular mass, arterial compliance, inflammation and coagulation abnormalities in the metabolic syndrome

• Register: ISRCTN
• Last refreshed on: 8 May 2017
• Main ID: ISRCTN04503926
• Date of registration: 07/02/2008
• Prospective Registration: No
• Primary sponsor: Central Manchester and Manchester Children's Hospitals NHS Trust (UK)
• Public title: Effect of valsartan on endothelial function, carotid intima-media thickness, left ventricular mass, arterial compliance, inflammation and coagulation abnormalities in the metabolic syndrome
• Scientific title: Effect of valsartan on endothelial function, carotid intima-media thickness, left ventricular mass, arterial compliance, inflammation and coagulation abnormalities in the metabolic syndrome
• Date of first enrolment: 01/01/2008
• Target sample size: 120
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN04503926
• Study type: Interventional
• Study design: Randomised placebo-controlled single-centre prospective study (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Rajdeep Khattar

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Metabolic syndrome
Nutritional, Metabolic, Endocrine
Metabolic syndrome

Intervention(s)

Those with metabolic syndrome (according to the definition in the hypothesis field) will be randomised to receive either valsartan 80 mg once daily or placebo using Interactive Web Response System (IWRS). A total of 120 subjects consisting of 40 normal controls and 40 patients in each treatment arm will be recruited.

Treatment duration is for 6 months. At the end of 6 months blood tests and scan measurements are repeated and compared with baseline values.

Primary Outcome(s)

Endothelial function. Baseline measurements and blood tests are done at study initiation and tests are repeated after 6 months and at this point primary and secondary endpoints are measured.

Secondary Outcome(s)

1. Carotid-intima media thickness
2. Left ventricular mass
3. Insulin resistance
4. Inflammatory markers
5. Coagulation factors

Baseline measurements and blood tests are done at study initiation and tests are repeated after 6 months and at this point primary and secondary endpoints are measured.

Secondary ID(s)

EudraCT Number: 2006-006986-18

2006-006986-18

Source(s) of Monetary Support

Novartis Pharmaceuticals UK Limited (UK)