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

January 21, 2020 updated by: Rania Reda Yacoub, Assiut University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Faculty of Medicine
        • Contact:
          • Rania Yacoub

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
Systolic function by echocardiography to100 Hepatitis C virus infected patients on continuous regimen ( sofosbuvir and daclatasvir )
Procedure: Systolic function by echocardiography

Echocardiography for evaluation of systolic function:

  • by biplane Simpson's method.
  • by speckle tracking:
Active Comparator: Control group
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

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (Actual)

May 25, 2017

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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