A Phase 4 interventional study of Cardiovascular risk in HCV patients in Hepatitis C and Cardiovascular Diseases, sponsored by Instituto de Investigación Marqués de Valdecilla. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-06-17.
Sponsored by Instituto de Investigación Marqués de Valdecilla · Phase 4 and Interventional
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.
Design:
Prospective interventional study.
Patients and methods:
Tracked on a population of 80 patients with CHC (estimated fibrosis F2-F3),
An evaluation of the CVR will be performed by determining biomarkers of endothelial activation and macrophage activation, measuring flow-mediated vasodilation and atherosclerotic damage.
All evaluations will take place prior (at baseline) and after antiviral treatment. Particularly, all determinations will be performed immediately before and 3, 12 and 24 months after the end of antiviral treatment.
In order to improve the diagnostic accuracy in terms of discriminating liver damage associated to Non Alcoholic Fatty Liver Disease (NAFLD) from HCV infection, the investigators will use the owl-liver® technique in all patients before and after treatment.
Sample size: Considering the primary endpoint the flow-mediated vasodilation (FMD), data have been reported on FMD of 7.6 ± 2.4% in healthy subjects and 5.1 ± 2.2% in subjects with risk factors (Dalli et al Rev Esp Cardiol 2002; 55: 928-35). Assuming these SD and a correlation coefficient of 0.3 between the two measurements, 80 patients will be needed to detect a change of 1% in vasodilation with an output of 90% and a significance level of 5%.
Variables and tasks:
Task 1. Assessment of endothelial function.
Task 2. Assessment of atherosclerotic damage. Common carotid, internal carotid and carotid bulb (bilateral) will be explored by ultrasound. The images will be electronically stored in DICOM format.
The analyzed parameters will be:
Task 3. Assessment of vascular risk. Classic and emerging vascular risk assessment.
h)-ECG with QTc interval measurement.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 80 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Instituto de Investigación Marqués de Valdecilla is the lead sponsor of 32 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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).
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in cIMT (Carotid intima-media thickness)
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).
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in the presence of carotid plaques
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.
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in ICAM-1 serum levels
Measurement of ICAM-1 (Intercellular Adhesion Molecule 1) serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in VCAM-1 serum levels
Measurement of Vascular cell adhesion molecule 1 (VCAM-1) serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in E-selectin serum levels
Measurement of E-selectin serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in P-selectin serum levels
Measurement of P-selectin serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in MCP-1 serum levels
Measurement of monocyte chemoattractant protein 1 (MCP-1) serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in galectin-3-binding protein serum levels
Measurement of galectin-3-binding protein serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in CD163 serum levels
Measurement of CD163 (Cluster of Differentiation 163) serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in hs-PCR serum levels
Measurement of hs-PCR serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in Lp(a) serum levels
Measurement of Lipoprotein(a) (Lp(a)) serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in VLDL serum levels
Measurement of VLDL serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in LDL serum levels
Measurement of LDL serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in HDL serum levels
Measurement of HDL serum levels at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Changes in HOMA
Measurement of HOMA (homeostasis model assessment) index at different times (see time frame)
Time frame: Basal and 3, 12 and 24 months after the end of treatment
Presence of Sustained Viral Response
Data on efficacy of treatment
Time frame: 3, 6 and 12 months after the end of treatment
Adverse events
Data on safety of treatments
Time frame: up to 24 weeks
Plan to share: No
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Instituto de Investigación Marqués de Valdecilla