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

Not Applicable

• Conditions: Hepatitis
• Interventions: Procedure: Systolic function by echocardiography; Procedure: Diastolic function by echocardiography

• Registration Number: NCT03166943
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Study Start: 2017-05-10
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-25
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. patients on continuous regimen (Sofosbuvir and daclatasvir) for 3 months
2. normal baseline trans thoracic echocardiography
3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Systolic function by echocardiography	Systolic function by echocardiography to100 Hepatitis C virus infected patients on continuous regimen ( sofosbuvir and daclatasvir )
Control group	Diastolic function by echocardiography	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 )

Primary Outcome Measures

Name	Time	Method
Percentage of patients with ventricular dysfunction	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

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt