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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03166943
Enrollment
130
Registered
2017-05-25
Start date
2017-05-10
Completion date
2020-12-31
Last updated
2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis

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 .

Interventions

PROCEDURESystolic function by echocardiography

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

PROCEDUREDiastolic 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients with ventricular dysfunction3 monthsThe 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

Countries

Egypt

Contacts

Primary ContactYehia Kishk, MD
ytkishk2002@yahoo.com00201011030011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026