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

Hepatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03166943
• Other study ID #: SSD
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: Yehia Kishk, MD
• Phone: 00201011030011
• Email: ytkishk2002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Virus Diseases

Intervention

Procedure:
• Systolic function by echocardiography
Echocardiography for evaluation of systolic function: by biplane Simpson's method. by speckle tracking:
• Diastolic function by echocardiography
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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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