Contact information
Type
Scientific
Contact name
Dr Rajdeep Khattar
ORCID ID
Contact details
Consultant Cardiologist
Manchester Heart Centre
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 6576
rajdeep.khattar@cmmc.nhs.uk
Additional identifiers
EudraCT/CTIS number
2006-006986-18
IRAS number
ClinicalTrials.gov 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
Acronym
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.
Hypothesis:
Angiotensin receptor blockade can reverse endothelial dysfunction in patients with metabolic syndrome.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised placebo-controlled single-centre prospective study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Metabolic syndrome
Intervention
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
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Valsartan
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 study start date
01/01/2008
Overall study end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
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
01/01/2008
Recruitment end date
31/12/2011
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Consultant Cardiologist
Manchester
M13 9WL
United Kingdom
Sponsor information
Organisation
Central Manchester and Manchester Children's Hospitals NHS Trust (UK)
Sponsor details
Research and Development
1st Floor Postgraduate Centre
Oxford Road
Manchester
M13 9WL
England
United Kingdom
+44 (0)161 276 3565
research.secretary@cmmc.nhs.uk
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Industry
Funder name
Novartis Pharmaceuticals UK Limited (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|