Status:
TERMINATED
Statins and Endothelial Function in Patients With Coarctation of the Aorta
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
American Heart Association
Conditions:
Coarctation of the Aorta
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, ...
Detailed Description
The study design is a randomized double-blind cross over clinical trial. Patients who meet inclusion criteria and no exclusion criteria will be enrolled. They will undergo a baseline cardiovascular as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00767572
Start Date
August 1 2008
End Date
July 1 2010
Last Update
October 14 2013
Active Locations (1)
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1
UCSF Medical Center, 505 Parnassus Ave
San Francisco, California, United States, 94143