Hepatitis C Treatment and Atherosclerosis

Completed

Conditions studied: Chronic Hepatitis C, Atherosclerosis

In brief

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

Key facts

Study ID

NCT00659256

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

70

Starts

2008-04-08

Expected to finish

2015-03-24

Last updated by the study team

2019-12-12

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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