Effect of Valsartan on Carotid Artery Disease

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The EFFERVESCENT trial is designed to evaluate the effects of a specific ARB, called valsartan, on atherosclerosis. The investigators want to know if treatment with valsartan will increase the blood levels of markers responsible for repair of the vessel wall, reduce oxidation and inflammation, improve the function of the blood vessels, and arrest or slow down the progression of atherosclerosis over time.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Valsartan

Criteria

Inclusion Criteria:

• > 0.65 mm intima-media thickness of the carotid artery measured by ultrasound

• Males aged 21-80 years or women without child bearing potential up to age 80

• Can be on concomitant therapy with aspirin, thiazide diuretics, calcium antagonists (for treatment of hypertension), or beta-receptor antagonists.

• May be on statin if on stable dose for at least 2 months before recruitment

Exclusion Criteria:

• Angiotensin-converting enzyme (ACE) inhibitor or ARB therapy in the previous 3 months.

• Initiation or change in dose of statin therapy within 2 months before the study

• Inability to return to Emory for follow-up blood drawing and MR imaging

• Age < 21 or > 80 years

• Premenopausal females with potential for pregnancy

• Current neoplasm

• Chronic renal failure [creatinine > 2.5 mg/dL]

• Diabetes with hemoglobin (Hb) A1c > 8.5

• Anticipated change in lipid lowering therapy

• Inability to give informed consent

• MR exclusion criteria

• Blood pressure > 140 mmHg systolic and > 90 mmHg diastolic

• Low-density lipoprotein (LDL) cholesterol level >130 mg/dl

• Acute coronary syndrome within 2 months

• Acute cerebrovascular accident within 2 months