Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in retinal vessel density after achieving blood pressure treatment target (OCT-A).
研究概览
简要总结
To evaluate whether in patients with initially poorly-controlled arterial hypertension, structural and functional differences in the retina and choroid remain after achieving a well-controlled blood pressure.
详细描述
Optical Coherence Tomography Angiography (OCT-A) is an ocular imaging technique which allows fast and non-invasive assessment of the retinal microvasculature. With the OCT-A, a reduction in capillary density in patients with arterial hypertension has been found. In animal experiments, this so called retinal capillary rarefaction could be reversed after administration of antihypertensive medication.
The main aim of the present study is to evaluate whether in patients with initially poorly-controlled hypertension, an increase in capillary density can be demonstrated, if patients achieve well-controlled blood pressure with antihypertensive medication. In addition changes in retinal oxygen metabolism and choroidal blood flow will be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and Women aged ≥ 18 years
- •Signed informed consent
- •Apart from hypertensive retinopathy, normal ophthalmic findings
- •Non-Smokers
- •Patients with initially diagnosed or pre-existing mild to moderate primary arterial hypertension (systolic office blood pressure ≥ 140 mmHg and/or diastolic office blood pressure ≥ 90 mmHg)
- •Planned initiation of antihypertensive medication or planned adaption of antihypertensive medication by the Department of Cardiology
- •Subject agrees to perform regular blood pressure self-measurements and to document blood pressure values in a diary
排除标准
- •Participation in a clinical trial in the three weeks preceding the study
- •Blood donation in the three weeks preceding the study
- •Symptoms of a clinically relevant illness in the three weeks preceding the study
- •History of family history of epilepsy
- •Secondary hypertension (e.g.: hyperaldosteronism, pheochromocytoma, renal artery stenosis, renal parenchymal diseases, Cushing-syndrome, Coarctatio aortae)
- •History of hypertensive encephalopathy or intracerebral bleeding
- •Diabetes mellitus Type 1 or Type 2
- •Pregnant or breast-feeding women
- •Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception
结局指标
主要结局
Change in retinal vessel density after achieving blood pressure treatment target (OCT-A).
时间窗: 12 weeks
As OCT devices are able to calculate the movements of erythrocytes, retinal perfusion can be visualized with Optical Coherence Tomography Angiography. No contrast media is necessary for the representation of retinal vessels.
次要结局
- Change in ocular blood flow after achieving blood pressure treatment target (LSFG).(12 weeks)
- Change in choroidal vascularity index after achieving blood pressure treatment target (EDI-OCT).(12 weeks)
- Change in retinal oxygen extraction after achieving blood pressure treatment target.(12 weeks)
- Change in ocular perfusion pressure and arterial blood pressure after achieving blood pressure treatment target.(12 weeks)
- Change in neurovascular coupling after achieving blood pressure treatment target (DVA).(12 weeks)
- Change in retinal oxygen saturation after achieving blood pressure treatment target (DVA).(12 weeks)
- Change in retinal vessel diameter after achieving blood pressure treatment target (DVA).(12 weeks)
研究者
Gerhard Garhofer
Principal Investigator
Medical University of Vienna