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

ISRCTN	ISRCTN04503926
DOI	https://doi.org/10.1186/ISRCTN04503926
EudraCT/CTIS number	2006-006986-18
Secondary identifying numbers	EudraCT Number: 2006-006986-18

Submission date: 29/10/2007
Registration date: 07/02/2008
Last edited: 12/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rajdeep Khattar
Scientific

Consultant Cardiologist
Manchester Heart Centre
Oxford Road
Manchester
M13 9WL
United Kingdom

Phone	+44 (0)161 276 6576
Email	rajdeep.khattar@cmmc.nhs.uk

Study information

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
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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 objectives	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
Health condition(s) or problem(s) studied	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
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Total = 120
Key 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
Key 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
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Consultant Cardiologist

Manchester
M13 9WL
United Kingdom

Sponsor information

Central Manchester and Manchester Children's Hospitals NHS Trust (UK)
Hospital/treatment centre

Research and Development
1st Floor Postgraduate Centre
Oxford Road
Manchester
M13 9WL
England
United Kingdom

Phone	+44 (0)161 276 3565
Email	research.secretary@cmmc.nhs.uk
Website	http://www.cmmc.nhs.uk/
"ROR"	https://ror.org/00he80998

Funders

Funder type

Industry

Novartis Pharmaceuticals UK Limited (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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