Targeting Microvascular Dysfunction in Young Hypertensive Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To demonstrate a significant difference in flow-mediated dilatation of the brachial artery and microvasculature between groups.
研究概览
简要总结
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 noninvasive technique known as ultrasound and with a simple blood test. The investigators 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. The investigators 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 < 50 years for men and < 60 years for women.
- •Female patients of childbearing potential must be using a medically accepted means of contraception (that is, interuterine device, oral contraceptive, implant, DepoProvera or barrier devices). Female patients of childbearing age will be screened with a pregnancy test.
- •Patients will be typically already on antihypertensive therapy.
- •Patients must have a level of understanding sufficient to complete all tests and examinations required by the protocol and are able to understand and give informed consent.
排除标准
- •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.
研究组 & 干预措施
Simvastatin
40mg Simvastatin once daily for 12 weeks followed by 4 week washout period followed by placebo for 12 weeks
干预措施: Simvastatin (Drug)
Placebo
Placebo for 12 weeks followed by 4 week washout period followed by 40mg Simvastatin once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
To demonstrate a significant difference in flow-mediated dilatation of the brachial artery and microvasculature between groups.
时间窗: 0, 3, 4 and 7 months
次要结局
未报告次要终点
研究者
Gary E McVeigh
Professor
Queen's University, Belfast