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

NCT ID: NCT03166943

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-10

Study Completion Date

2020-12-31

Brief Summary

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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

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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 .

Conditions

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Hepatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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study group

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

Group Type EXPERIMENTAL

Systolic function by echocardiography

Intervention Type PROCEDURE

Echocardiography for evaluation of systolic function:

* by biplane Simpson's method.
* by speckle tracking:

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 )

Group Type ACTIVE_COMPARATOR

Diastolic function by echocardiography

Intervention Type 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.

Interventions

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Systolic function by echocardiography

Echocardiography for evaluation of systolic function:

* by biplane Simpson's method.
* by speckle tracking:

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Rania Reda Yacoub

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yehia Kishk, MD

Role: CONTACT

00201011030011

Facility Contacts

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Rania Yacoub

Role: primary

Other Identifiers

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SSD

Identifier Type: -

Identifier Source: org_study_id

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