Hepatitis C Eradication and Progression of Atherosclerosis
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| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Chronic Hepatitis C - Atherosclerosis |
| Purpose: |
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This study will examine the effects of treatment for hepatitis C on atherosclerosis, or
hardening of the arteries. Hepatitis C is a disease of the liver caused by a virus that can
cause permanent damage to that organ. Treatment can clear the virus in at least half of
patients and reduce the risk of serious complications of the disease. Atherosclerosis is an
accumulation of cholesterol and fat in the arteries that can narrow blood vessels, leading
to chest pain, heart attack or stroke.
Because the liver controls cholesterol and fat levels in the blood, hepatitis C infection
may be a risk factor for atherosclerosis by increasing cholesterol and fat in blood vessels.
Treatment of the hepatitis C may reduce the risk of atherosclerosis and its consequences.
This study will determine what effect hepatitis C treatment has on the rate of
atherosclerosis and narrowing of blood vessels and on the risk of heart attack or stroke.
Patients 30 years of age and older with current or past infection with hepatitis C may be
eligible for this study. Participants undergo the following tests and procedures:
- Questionnaires regarding risk factors for heart disease and stroke
- Measurements of blood pressure, heart rate, weight, height, waist and hips
- Blood tests
- CT scans and ultrasound tests to measure the degree of blood vessel hardening and
narrowing in the heart and neck region
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| Study Summary: |
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Hepatitis C virus (HCV) infection is associated with changes in lipid metabolism in the
liver and the peripheral blood. Patients with chronic hepatitis C infection tend to have low
levels of cholesterol and LDL-cholesterol. These levels increase in many patients after
treatment and successful eradication of the virus. However, it is not known whether this
increase is associated with increased cardiovascular risk and thus may increase their risk
for atherosclerotic disease. To determine whether eradication of HCV affects atherosclerosis
progression, we propose to examine up to 200 patients with chronic hepatitis C for markers
of atherosclerosis and the risk of its complications. Up to 100 patients who have cleared
HCV and recovered will be matched and compared to patients who failed to respond and
continue to have chronic hepatitis C. The atherosclerosis assessment will include careful
history for cardiovascular risk factors, a battery of blood tests for lipid levels and
relevant biomarkers followed by specialized imaging tests of the carotid and coronary
arteries, including ultrasound imaging of intima-media thickness of the carotid arteries and
computerized axial tomography of the heart and coronary arteries. The primary end point in
the assessment will be differences in maximal carotid intima media thickness and secondary
end points will include differences in coronary artery calcium score, Framingham risk scores
and other measurements or atherosclerosis. This cross-sectional study will set the stage for
a more formal prospective assessment of cardiovascular risk factors and evidence of coronary
and cerebrovascular disease among patients being treated with antiviral agents.
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| Criteria: |
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- INCLUSION CRITERIA:
Age equal to or greater than 30 years, male or female
Written informed consent
All ethnicities
Viral hepatitis status:
- Cases:
- History of chronic hepatitis C defined by past positivity for serum HCV-RNA, HCV
antibody and elevated serum alanine or aspartate aminotransferase levels for at
least 6 months before start of treatment
- Genotype 1, 2 or 3
- Absence of detectable serum HCV-RNA by PCR on screening visit and on a previous
test, at least 3 months apart. Both tests have to be performed at least 24 weeks
after cessation of therapy
- Past treatment with interferon alfa (standard or pegylated) for at least 12
weeks
- At least 12 months after end of interferon treatment
- Normal liver enzymes on screening visit
- Genotype 1 controls:
- Detectable serum HCV-RNA on screening visit
- Past treatment with interferon alfa (standard or pegylated) for at least 12
weeks
- At least 12 months after end of interferon treatment
- Age (difference less than or equal to 3 years), sex and race-matched with
genotype 1 cases
- Genotype 2 and 3 controls:
- Detectable serum HCV-RNA on screening visit
- If previously treated with interferon alfa (standard or pegylated) - at least 12
months elapsed from the end of treatment
- Age (difference less than or equal to 3 years), sex, race and genotype-matched
with genotype 2 and 3 cases
EXCLUSION CRITERIA:
Pregnancy or lactation
History of clinical atherosclerotic disease manifest as:
- Ischemic cerebrovascular accident (CVA), transient ischemic accident (TIA) or
radiological evidence of stroke.
- Proven coronary artery disease - history of myocardial infarction, need for coronary
angioplasty or coronary artery bypass graft, anginal syndrome with confirmatory
stress test or cardiac imaging.
- Symptomatic peripheral vascular disease, history of angioplasty or surgical bypass.
- History of carotid artery surgery or angioplasty
- Patients with overt atherosclerotic disease can be included if the first
manifestation of that disease appeared at least 3 years after cessation of interferon
treatment. Control patients who were never treated in the past will not be included
if there is an overt manifestation of atherosclerosis.
Diabetes mellitus - unless fasting blood sugar can be maintained within normal limits and
HBA1C less than 7 without the need for pharmacologic intervention
Hypertension - unless blood pressures can be maintained for greater than 6 months within
normal limits without the need for pharmacologic intervention
Current treatment with cholesterol lowering medications
Chronic renal failure (creatinine clearance less than 50 ml)
Known HIV infection
HCV genotype 4, 5, 6 or mixed infection.
Other causes of liver disease apart from hepatitis C (hepatitis B, alcoholic liver
disease, NASH, autoimmune hepatitis, PBC etc.). Bland, non-alcoholic hepatic steatosis
will not constitute an exclusion criterion
History of trauma to the neck, surgery or deformity precluding sonographic visualization
of the carotid arteries
Inability to sign or understand the informed consent form
A contraindication or unwillingness to undergo the coronary calcium score CT scan will not
be an exclusion criterion, as this is not a primary end-point, as long as the participant
is willing to undergo an IMT measurement.
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| NCT ID: |
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NCT00659256 |
| Primary Contact: |
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Principal Investigator
Yaron Rotman, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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