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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03166943
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Rania Reda Yacoub, Assiut University

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.

Condition or disease Intervention/treatment Phase
Hepatitis Procedure: Systolic function by echocardiography Procedure: Diastolic function by echocardiography Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166943


Contacts
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Contact: Yehia Kishk, MD 00201011030011 ytkishk2002@yahoo.com

Locations
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Egypt
Faculty of Medicine Recruiting
Assiut, Egypt
Contact: Rania Yacoub         
Sponsors and Collaborators
Assiut University
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Responsible Party: Rania Reda Yacoub, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03166943    
Other Study ID Numbers: SSD
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections