Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endothelial Dysfunction and Subclinical Atheromatosis in Chronic HCV Infection. Response to DAA Agents. (C-Endys)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02802280
Recruitment Status : Unknown
Verified June 2016 by Instituto de Investigación Marqués de Valdecilla.
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : June 17, 2016
Sponsor:
Collaborator:
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
Instituto de Investigación Marqués de Valdecilla

Brief Summary:

Hypothesis: In addition to the liver deleterious effects, Chronic Hepatitis C (CHC) can cause changes in other organs highlighting the increased cardiovascular risk (CVR) through accelerated atherosclerosis, whose consequences may persist even after healing infection with new antiviral treatments. This can have major impact on the health system. Obtaining a Sustained Virological Response (SVR) with a free Interferon (IFN) antiviral treatment is probably able to reverse, at least partially, increased vascular risk induced by Hepatitis C virus (HCV) and perhaps ultimately reverse the subclinical atherosclerosis.

Aims: To study the presence of early-subclinical atherosclerotic disease (endothelial dysfunction and subclinical atherosclerosis) in patients with CHC and evaluate the influence of treatment in the short and medium term on the CVR derived. Studying these same issues but in patients with established atherosclerotic disease.


Condition or disease Intervention/treatment Phase
Hepatitis C Cardiovascular Diseases Other: Cardiovascular risk in HCV patients Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Personalized Medicine in HCV Chronic Infection. Endothelial Dysfunction and Subclinical Atheromatosis in Patients With HCV Infection. Characterization and Potential Reversibility With Direct Antiviral Agents.
Study Start Date : October 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cardiovascular risk in HCV patients

Intervention:

The only intervention to be carried out along the study will consist of a complete evaluation of cardiovascular risk of HCV patients both at baseline (pre-treatment) and after HCV treatment, through performing different tests (see below)

Chronic HCV patients who are going to be treated with new DAAs according to current guidelines will be studied at different times before and after the end of the treatment.

The participation in the study will not influence neither the indication to treat nor the treatment used.

Anti-HCV regimens will be used according to clinical practice as indicated into the current guidelines

Other: Cardiovascular risk in HCV patients

Cardiovascular risk assessement (through Flow-mediated vasodilatation "FMV", measurement of endothelial function biomarkers, carotid ultrasound, etc.)

This is a prospective study. The only intervention planned will consist of performing different tests that define the individual cardiovascular risk. These tests will be carried out on a single group cohort at different times.

Notwithstanding, the investigators will record the exposure to DAA to assess any change in CVR.

Anti-HCV regimens will be used according to clinical practice as indicated into the current guidelines (1)

(1)European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. PubMed PMID: 25911336.





Primary Outcome Measures :
  1. Changes in Flow mediated dilatation (FMD) [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    FMD: Vasodilation mediated by ultrasound brachial flow through the rate of increase of brachial artery diameter (d2) as compared to baseline (d1) after a ischemia time (300 mmHg) for 4 minutes (FMD = (d2-d1) / d1 (x 100).


Secondary Outcome Measures :
  1. Changes in cIMT (Carotid intima-media thickness) [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    cIMT (Carotid intima-media thickness) will be assessed by carotid ultrasound. It is defined as the distance between the interface of the carotid lumen with arterial intima and the interface of medium with adventitia of the distal arterial wall. They will be measured on the back wall in a free-plaque area in the common carotid (cIMT CC) in the carotid bulb (cIMT -B), and internal carotid (cIMT -CI).

  2. Changes in the presence of carotid plaques [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Presence of carotid plaques in these territories (common carotid, carotid bulb and internal carotid). Plaque will be defined following the Mannheim criteria. It will be assessed by carotid ultrasound image.

  3. Changes in ICAM-1 serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of ICAM-1 (Intercellular Adhesion Molecule 1) serum levels at different times (see time frame)

  4. Changes in VCAM-1 serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of Vascular cell adhesion molecule 1 (VCAM-1) serum levels at different times (see time frame)

  5. Changes in E-selectin serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of E-selectin serum levels at different times (see time frame)

  6. Changes in P-selectin serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of P-selectin serum levels at different times (see time frame)

  7. Changes in MCP-1 serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of monocyte chemoattractant protein 1 (MCP-1) serum levels at different times (see time frame)

  8. Changes in galectin-3-binding protein serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of galectin-3-binding protein serum levels at different times (see time frame)

  9. Changes in CD163 serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of CD163 (Cluster of Differentiation 163) serum levels at different times (see time frame)

  10. Changes in hs-PCR serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of hs-PCR serum levels at different times (see time frame)

  11. Changes in Lp(a) serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of Lipoprotein(a) (Lp(a)) serum levels at different times (see time frame)

  12. Changes in VLDL serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of VLDL serum levels at different times (see time frame)

  13. Changes in LDL serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of LDL serum levels at different times (see time frame)

  14. Changes in HDL serum levels [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of HDL serum levels at different times (see time frame)

  15. Changes in HOMA [ Time Frame: Basal and 3, 12 and 24 months after the end of treatment ]
    Measurement of HOMA (homeostasis model assessment) index at different times (see time frame)

  16. Presence of Sustained Viral Response [ Time Frame: 3, 6 and 12 months after the end of treatment ]
    Data on efficacy of treatment

  17. Adverse events [ Time Frame: up to 24 weeks ]
    Data on safety of treatments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCV infected patients (aged 18-75 yr)
  • Naive or failure to previous treatments
  • Liver fibrosis F2-F3 in Fibroscan/liver biopsy
  • Accept the study and sign the CI

Exclusion Criteria:

  • Known cardiovascular diseases
  • Does not meet the above criteria
  • VIH or other viral coinfection
  • Hepatocarcinoma
  • Pregnancy

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): NCT02802280


Contacts
Layout table for location contacts
Contact: Javier Crespo García, MDPhD 34 942202544 javiercrespo1991@gmail.com
Contact: Antonio Cuadrado Lavín, MDPhD 34 942202544 acuadrado@humv.es

Locations
Layout table for location information
Spain
Hospital Universitario Marqués de Valdecilla Recruiting
Santander, Cantabria, Spain, 39008
Contact: Javier Crespo García, MDPhD    34 942202544    javiercrespo1991@gmail.com   
Sponsors and Collaborators
Instituto de Investigación Marqués de Valdecilla
Ministerio de Economía y Competitividad, Spain
Investigators
Layout table for investigator information
Principal Investigator: Javier Crespo García, MDPhD Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla. Professor at the Universidad de Cantabria

Publications:
Layout table for additonal information
Responsible Party: Instituto de Investigación Marqués de Valdecilla
ClinicalTrials.gov Identifier: NCT02802280    
Other Study ID Numbers: C-Endys PI15/02138
PI15/02138 ( Other Grant/Funding Number: Spanish Ministry of Economy and Competitiveness )
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Instituto de Investigación Marqués de Valdecilla:
endothelial dysfunction
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Hepatitis C
Cardiovascular Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections