Statins and Endothelial Function in Patients With Coarctation of the Aorta

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Coarctation of the Aorta

In brief

Coarctation of the aorta (CoA) accounts for approximately 8% of all congenital heart problems. Patients with CoA are well known to have an increased rates of early heart disease, high blood pressure, heart failure and stroke. Abnormal arterial function (dilation and constriction of the blood vessels) has been observed in these patients and likely contributes to the increased risk of cardiovascular problems. However, therapies targeted at improving arterial function have not been investigated in this population. Statin therapy (cholesterol medicines like Lipitor) have been studied in other subgroups of patients with abnormal arterial function and has shown benefit in improving arterial function and reducing risk of cardiovascular problems. The investigators hypothesize that patients with CoA have abnormal arterial function leading to increased cardiovascular risk. We further hypothesize that statin therapy may improve this problem. We plan to compile a complete database of information regarding these patients cardiovascular health and propose to then examine the effect of atorvastatin (Lipitor) on arterial function as measured by changes in arm arterial function tests.

Key facts

Study ID

NCT00767572

Run by

University of California, San Francisco

People needed

12

Starts

2008-08-01

Expected to finish

2010-07-01

Last updated by the study team

2013-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients over the age of 18 years with repaired coarctation of the aorta (CoA) and willing to participate in all portions of the study including follow up, blood draws, urine sample, echocardiogram, MRI, brachial artery flow-mediated dilatation (FMD) testing, Carotid Intima Media Thickness (CIMT) testing and statin administration.

You may not qualify if…

• patients who are pregnant, nursing, or planning on becoming pregnant in the subsequent year
• current smokers
• patients with documented coronary artery disease (CAD), other systemic inflammatory disorder such as systemic lupus erythematosis or rheumatoid arthritis
• patients already on statin therapy or who have had previous adverse effects to statin therapy
• patients with hepatic transaminases >2X the upper limit of normal
• patients with creatinine clearance <60mg/dL
• patients who have implanted devices such as pacemakers or defibrillators that preclude MRI testing
• patients with low blood pressure at baseline (< 90/50)
• patients who are unwilling or unable to comply with the aforementioned portions of the study

Where it is running

• UCSF Medical Center, 505 Parnassus Ave — San Francisco, California, United States

Full record on ClinicalTrials.gov

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