Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Rajdeep Khattar


Contact details

Consultant Cardiologist
Manchester Heart Centre
Oxford Road
M13 9WL
United Kingdom
+44 (0)161 276 6576

Additional identifiers

EudraCT number

2006-006986-18 number

Protocol/serial number

EudraCT Number: 2006-006986-18

Study information

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


Study hypothesis

The study is conducted on patients with metabolic syndrome. The National Cholesterol Education Program Adult Treatment Panel definition of metabolic syndrome will be applied and includes the presence of three or more of the following components:
1. Waist girth greater than 102 cm in men or greater than 94 cm in women
2. Serum triglycerides greater than 1.7 mmol/l
3. Serum High Density Lipoprotein (HDL)-cholesterol less than 1.04 mmol/l
4. Fasting plasma glucose greater than 6.1 mmol/l
5. Blood pressure greater than 130/85 mmol/l

Null hypothesis:
Enothelial function in patients with metabolic syndrome does not differ significantly from endothelial function in patients with only two or fewer components of metabolic syndrome or control participants. Also, angiotensin receptor blockade has no role in the reversal of endothelial dysfunction.

Angiotensin receptor blockade can reverse endothelial dysfunction in patients with metabolic syndrome.

Ethics approval

Not provided at time of registration

Study design

Randomised placebo-controlled single-centre prospective study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Metabolic syndrome


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.

Intervention type



Not Applicable

Drug names


Primary outcome measure

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 measures

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.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants

Total = 120

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Consultant Cardiologist
M13 9WL
United Kingdom

Sponsor information


Central Manchester and Manchester Children's Hospitals NHS Trust (UK)

Sponsor details

Research and Development
1st Floor Postgraduate Centre
Oxford Road
M13 9WL
United Kingdom
+44 (0)161 276 3565

Sponsor type




Funder type


Funder name

Novartis Pharmaceuticals UK Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/04/2017: No publications found in PubMed, verifying study status with principal investigator