NCT02802280

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

June 13, 2016

Last Update Submit

June 15, 2016

Conditions

Hepatitis CCardiovascular Diseases

Keywords

endothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • Changes in Flow mediated dilatation (FMD)

    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).

    Basal and 3, 12 and 24 months after the end of treatment

Secondary Outcomes (17)

  • Changes in cIMT (Carotid intima-media thickness)

    Basal and 3, 12 and 24 months after the end of treatment

  • Changes in the presence of carotid plaques

    Basal and 3, 12 and 24 months after the end of treatment

  • Changes in ICAM-1 serum levels

    Basal and 3, 12 and 24 months after the end of treatment

  • Changes in VCAM-1 serum levels

    Basal and 3, 12 and 24 months after the end of treatment

  • Changes in E-selectin serum levels

    Basal and 3, 12 and 24 months after the end of treatment

  • +12 more secondary outcomes

Study Arms (1)

Cardiovascular risk in HCV patients

OTHER

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

Interventions

Cardiovascular risk in HCV patientsOTHER

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.

Cardiovascular risk in HCV patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Related Publications (4)

  • 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. No abstract available.

    PMID: 25911336BACKGROUND

  • Petta S, Macaluso FS, Craxi A. Cardiovascular diseases and HCV infection: a simple association or more? Gut. 2014 Mar;63(3):369-75. doi: 10.1136/gutjnl-2013-306102. Epub 2013 Dec 2. No abstract available.

    PMID: 24295849BACKGROUND

  • Negro F. Facts and fictions of HCV and comorbidities: steatosis, diabetes mellitus, and cardiovascular diseases. J Hepatol. 2014 Nov;61(1 Suppl):S69-78. doi: 10.1016/j.jhep.2014.08.003. Epub 2014 Nov 3.

    PMID: 25443347BACKGROUND

  • Perticone M, Maio R, Tassone EJ, Tripepi G, Di Cello S, Miceli S, Caroleo B, Sciacqua A, Licata A, Sesti G, Perticone F. Insulin-resistance HCV infection-related affects vascular stiffness in normotensives. Atherosclerosis. 2015 Jan;238(1):108-12. doi: 10.1016/j.atherosclerosis.2014.11.025. Epub 2014 Nov 29.

    PMID: 25461736BACKGROUND

MeSH Terms

Conditions

Hepatitis CCardiovascular Diseases

Interventions

Heart Disease Risk Factors

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Risk FactorsRiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Javier Crespo García, MDPhD

    Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla. Professor at the Universidad de Cantabria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Crespo García, MDPhD

CONTACT

34 942202544javiercrespo1991@gmail.com

Antonio Cuadrado Lavín, MDPhD

CONTACT

34 942202544acuadrado@humv.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 16, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

June 17, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)