Hypertension Related Damage to the Microcirculation in South Asian: Emergence,Predictive Power and Reversibility
试验速览
- 阶段
- 不适用
- 入组人数
- 2,880
- 试验地点
- 2
- 主要终点
- Primary outcome would be abnormal retinal geometry defined as the composite outcome of a) abnormal arteriolar length: diameter, b) narrowed branching angles, or c) disturbed junction exponents.
研究概览
简要总结
Damage to very small blood vessels is a consequence, but can also precede high blood pressure. Such damage, measured by disturbances in the vessels in the retina (back of the eye) is a strong predictor of heart disease and stroke. South Asian people have one of the highest rates of hypertension in the world (30% in adults). In Pakistan, this is usually severe, undetected and untreated. The Wellcome Trust has already funded a study of blood pressure control in adults and children in this population. We propose a substudy, taking photographs of the retina and making measurements of the vessels, to determine whether such blood pressure related changes occur at an early age in young children with a family history of high blood pressure compared to those without, whether such changes predict an increase in blood pressure over time, and whether, in adults, such changes can be reversed by blood pressure treatment. The hypothesis of our study is: young offspring of South Asian people with hypertension have a disturbed microcirculation, as assessed by abnormalities of retinal vessels, compared to offspring of normotensive parents. Our 2nd hypothesis is: Abnormal retinal vascular geometry will improve proportionately to achieved reductions in BP.
详细描述
Background
The role of the microcirculation is increasingly being recognized in the etiopathogenesis of cardiovascular disease. Delays in this recognition are in part due to the difficulty of studying the microcirculation non-invasively, in large numbers of individuals. Retinal vessels provide an easily accessible "window" to the microcirculation. Abnormalities of the retinal vasculature have been shown to be associated with cardiovascular risk factors and all cause mortality. Non-invasive assessment of the retinal circulation presents a valuable opportunity to study the structure and function of the microvasculature
Aims of the project
To compare geometry of retinal microvasculature of 1) hypertensive vs normotensive adults, 2) children aged 10 to 14 years of hypertensive parent (test group) versus normotensive parent (control group), and, 3) to assess the impact of blood pressure lowering on these changes over 2 years.
Primary outcome would be abnormal retinal geometry defined as the composite outcome of a) abnormal arteriolar length: diameter ratios (a measure of relative arteriolar narrowing), b) narrowed branching angles (an indicator of arteriolar rarefaction), or c) disturbed junction exponents (a marker of endothelial dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 9 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects aged 9 years or over residing in randomly selected communities
排除标准
- •Those who have severe co-morbid conditions
- •Patients with known history of glaucoma will be excluded from our study because instillation of mydriatic drops was thought to be hazardous for them.
结局指标
主要结局
Primary outcome would be abnormal retinal geometry defined as the composite outcome of a) abnormal arteriolar length: diameter, b) narrowed branching angles, or c) disturbed junction exponents.
次要结局
未报告次要终点
