Hypertension
Conditions
Interventions
Trade Name: Losartan (Cozaar)
Product Name: Losartan
Pharmaceutical Form: Tablet
Trade Name: Simvastatin
Product Name: Simvastatin
Pharmaceutical Form: Capsule*
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for the study, all of the following criteria must be met: • All patients must have a diagnosis of essential hypertension with off treatment systolic pressure >140 mmHg and/or diastolic pressure >90 mmHg, measured at rest in the seated position on at least two separate occasions, at least 2 weeks apart. • Patients will be =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: • A history of diabetes mellitus, coronary artery or cerebrovascular disease, hypertensive retinopathy, hypertensive nephropathy, left ventricular hypertrophy or hyperlipidaemia warranting treatment as defined by the latest NICE guidelines which recommend an age based treatment strategy rather than one driven purely by lipid levels in isolation. • Abnormal baseline liver function (defined as AST or ALT > 3 times upper limit of normal), raised baseline creatinine kinase (CK) (defined as CK > 200 mmol/L), severe renal impairment (defined as estimated glomerular filtration rate (eGFR) < 30 mls/minute) or previous adverse event relating to either an ARB or statin in the past. • Female patients will be excluded if they are pregnant, intend to be pregnant or are lactating. Female patients of childbearing age will be screened with a pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cholesterol and blood pressure lowering tablets have been shown to be of benefit in patients with established high blood pressure. High blood pressure is a very common medical condition that can lead to vascular complications i.e. problems with the blood vessels in the body. One way of detecting early changes in these blood vessels as a result of high blood pressure is to measure their compliance/flexibility with a non-invasive technique known as ultrasound and with a simple blood test. We are trying to establish whether these early changes in blood vessels can be significantly improved by the use of both a cholesterol and blood pressure lowering tablet at an earlier stage than is currently advised. We hope that the early combination of these tablets will prove more effective than the use of a blood pressure lowering tablet by itself and therefore possibly reduce the risk of long term complications developing.;Secondary Objective: To demonstrate a statistically significant improvement in the balance of blood markers (nitric oxide and superoxide) and measures of oxidative stress in patients treated with both cholesterol and blood pressuring lowering tablets compared with standard management.;Primary end point(s): The difference between the groups in flow-mediated dilatation in the forearm from baseline to the final measurement on the last visit. | — |
Countries
United Kingdom
Outcome results
None listed