the Possible Effect of the Antiviral Inhibitors for Treatment of Hepatitis C Virus Infection in Cardiac Function

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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 .

Official Title
-----------------
An Investigative Study on the Possible Effect of the Antiviral Inhibitors (Sofosbuvir and Daclatasvir) for Treatment of Hepatitis C Virus Infection in Cardiac Function

Conditions
-----------------
Hepatitis

Intervention / Treatment
-----------------
* Procedure: Systolic function by echocardiography
* Procedure: Diastolic function by echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients on continuous regimen (Sofosbuvir and daclatasvir) for 3 months normal baseline trans thoracic echocardiography normal Electrocardiography Exclusion Criteria: 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>Systolic function by echocardiography to100 Hepatitis C virus infected patients on continuous regimen ( sofosbuvir and daclatasvir ) | Procedure: Systolic function by echocardiography<br>* Echocardiography for evaluation of systolic function: by biplane Simpson's method. by speckle tracking:<br>|
| Active Comparator: Control group<br>Diastolic function by echocardiography age and sex matched group of 30 patients with Hepatitis C virus who did not receive antiviral treatment ( sofosbuvir and daclatasvir ) | Procedure: Diastolic function by echocardiography<br>* Echocardiography for evaluation of diastolic function: Left atrial Volume Mitral Inflow Patterns Pulsed wave Doppler Mitral inflow patterns include normal, impaired left ventricular relaxation, pseudonormal, and restrictive left ventricular filling patterns. Tissue Doppler Annular Early and Late Diastolic Velocities Pulsed wave tissue doppler imaging Primary measurements include the systolic , early diastolic, and late diastolic velocities.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with ventricular dysfunction | 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 | 3 months |