An Investigative Study on the Possible Effect of the Antiviral Inhibitors (Sofosbuvir and Daclatasvir) for Treatment of Hepatitis C Virus Infection in Cardiac Function
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Percentage of patients with ventricular dysfunction
研究概览
简要总结
It has been known for many years that the heart and the liver are intimately related. There is a mutual interaction between the function of the heart and the liver and a broad spectrum of acute and chronic entities that affect both the heart and the liver. Chronic hepatitis C virus infection affects more than 3% (170 million) of the world's population.
详细描述
Assessment of systolic function by echocardiography will be done to 100 hepatitis C virus infected patients who receive antiviral treatment (sofosbuvir and daclatasvir) by biplane simpson's method and by speckle tracking.
Assessment of diastolic function by echocardiography to 30 hepatitis C virus infected patients who will not receive antiviral treatment, by left atrium volume , mitral inflow pattern , tissue doppler annular early and late diastolic velocities .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients on continuous regimen (Sofosbuvir and daclatasvir) for 3 months
- •normal baseline trans thoracic echocardiography
- •normal Electrocardiography
排除标准
- •1 - Diabetes mellitus, hypertension and chronic kidney disease. 2- Hepatitis C virus patients with any baseline Electrocardiography abnormality.
- •3- Patients with underlying any structural heart disease.
结局指标
主要结局
Percentage of patients with ventricular dysfunction
时间窗: 3 months
The percentage of ventricular dysfunction in hepatitis C virus patients who received antiviral treatment in comparison with patients with hepatitis C virus who didn't receive antiviral treatment
次要结局
未报告次要终点
研究者
Rania Reda Yacoub
principal investigator
Assiut University