Cardiovascular Diseases Clinical Trial
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.
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.
1. -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).
2. -Endothelial function biomarkers: ICAM-1, VCAM-1, E-selectin, P-selectin, MCP-1,
angiopoietin-2, sTWEAK and ADMA.
3. - Macrophage activation biomarkers: Gal-3BP, sCD163 and sCD14.
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:
1. cIMT (Carotid intima media thickness and carotid intima-media thickness) 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. Presence of carotid plaques in these territories. Plaque will be defined following the
Mannheim criteria.
3. Presence of atherosclerotic plaque: to distinguish between focal and diffuse
thickening. In the focal plate area, maximum thickness and Gray Scale Median (GSM) will
be quantified. In the diffuse thickening (IMT> 1.5 mm) only the GSM will be quantified.
Task 3. Assessment of vascular risk. Classic and emerging vascular risk assessment.
1. -Study of classic risk factors: through REGICOR and Framingham Score tables. Fatty
Liver Index to exclude or confirm NASH (BMI, waist circumference, triglycerides and
GGT). Metabolic syndrome will be detected by the NCEP-ATPIII.
2. - Study of emerging vascular risk factors, including proinflammatory factors. In this
way, the investigators will analyze the plasma levels hcPCR, homocysteine, Lp(a),
pentraxin 3, SAA, oxidized LDL, PON1, PCSK9 and elevated plasma levels of von
Willebrand factor factor (VWF)
3. - Qualitative lipoprotein changes: the total concentration of lipoprotein (VLDL, LDL,
HDL) will be determined as well as their composition (total cholesterol, triglycerides,
phospholipids, protein, apolipoprotein B, lipoprotein ratio / total triglyceride mass
VLDL, LDL and HDL, number of VLDL, LDL and HDL, cholesterol molecules per particle and
triglyceride molecules per particle).
4. - Insulin resistance by HOMA.
5. -HbA1c
6. - Rx Thorax.
h)-ECG with QTc interval measurement.
;
Intervention Model: Single Group Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|