Statins and Endothelial Function in Patients With Coarctation of the Aorta
Condition: Coarctation of the Aorta
MeSH terms: Aortic Coarctation
Intervention: atorvastatin; Sugar pill
Intervention description: Atorvastatin 80mg daily vs. placebo daily X 12 weeks, then 4 week washout period, then cross over groups to complete another 12 weeks. (Total study time is 28 weeks (12+4+12); atorvastatin 80mg daily vs. placebo daily X 12 weeks, then 4 week washout, then cross over groups X 12 weeks. Total study time is 28weeks (12+4+12).
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coarctation of the aorta; cross over design; atorvastatin; endothelial function

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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