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

NCT03166943 | Unknown

• 1 other identifier: SSD
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

study group

EXPERIMENTAL

Systolic function by echocardiography to100 Hepatitis C virus infected patients on continuous regimen ( sofosbuvir and daclatasvir )

Procedure: Systolic function by echocardiography

Control group

ACTIVE COMPARATOR

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

Interventions

Systolic function by echocardiography PROCEDURE

Echocardiography for evaluation of systolic function: * by biplane Simpson's method. * by speckle tracking:

study group

Diastolic function by echocardiography PROCEDURE

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.

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients on continuous regimen (Sofosbuvir and daclatasvir) for 3 months
• normal baseline trans thoracic echocardiography
• normal Electrocardiography

You may not qualify if:

• Diabetes mellitus, hypertension and chronic kidney disease. 2- Hepatitis C virus patients with any baseline Electrocardiography abnormality.
• Patients with underlying any structural heart disease.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

Yehia Kishk, MD

CONTACT

00201011030011; ytkishk2002@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 25, 2017
• Study Start: May 10, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)