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| Effect of valsartan on endothelial function, carotid intima-media thickness, left ventricular mass, arterial compliance, inflammation and coagulation abnormalities in the metabolic syndrome |
| Source of record | UK Trials |
| ISRCTN | ISRCTN04503926 |
| Date ISRCTN assigned | 07/02/2008 |
| Local reference number(s) | Eudract Number: 2006-006986-18 |
| 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 | |
| Acronym | N/A |
| Disease/condition/study domain | 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. Our hypothesis: Our hypothesis is that angiotensin receptor blockade can reverse endothelial dysfunction in patients with metabolic syndrome. |
| Design/methodology | A randomised, placebo-controlled, single centre, prospective study |
| Research ethics review | Ethics application is being submitted to the National Research Ethics Service (NRES), pending as of 29/10/2007. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 31/12/2011 |
| Status of trial | Ongoing |
| Target number of participants | Total = 120 |
| Interventions | 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 measure(s) | The primary objective is to test the hypothesis that angiotensin receptor blockade can reverse endothelial dysfunction. The primary endpoint is the change in 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 measure(s) | The secondary objectives are to assess the changes in other surrogate markers of cardiovascular disease.The secondary endpoints include change in: 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. |
| Sources of funding | Novartis Pharmaceuticals UK Limited (UK) |
| Sponsor name | Central Manchester and Manchester Children's Hospitals NHS Trust (UK) |
| Sponsor details | Research and Development 1st Floor Postgraduate Centre Oxford Road Manchester United Kingdom M13 9WL |
| Sponsor telephone | +44 (0)161 276 3565 |
| Sponsor email | research.secretary@cmmc.nhs.uk |
| Sponsor website | http://www.cmmc.nhs.uk/ |
| Contact name | Dr Rajdeep Khattar |
| Contact details | Consultant Cardiologist Manchester Heart Centre Oxford Road Manchester United Kingdom M13 9WL |
| Contact telephone | +44 (0)161 276 6576 |
| Contact email | rajdeep.khattar@cmmc.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN04503926 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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