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 |
| Clinical Trials Information System (CTIS) | 2006-006986-18 |
| Protocol serial number | EudraCT Number: 2006-006986-18 |
| Sponsor | Central Manchester and Manchester Children's Hospitals NHS Trust (UK) |
| Funder | Novartis Pharmaceuticals UK Limited (UK) |
- 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
Scientific
Consultant Cardiologist
Manchester Heart Centre
Oxford Road
Manchester
M13 9WL
United Kingdom
| Phone | +44 (0)161 276 6576 |
|---|---|
| rajdeep.khattar@cmmc.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled single-centre prospective study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Valsartan |
| Primary outcome measure(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. |
| Key secondary outcome measure(s) |
1. Carotid-intima media thickness |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Consultant Cardiologist
Manchester
M13 9WL
United Kingdom
M13 9WL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/04/2017: No publications found in PubMed, verifying study status with principal investigator
