Statins and Endothelial Function in Patients With Coarctation of the Aorta
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|ClinicalTrials.gov Identifier: NCT00767572|
Recruitment Status : Terminated (low enrollment)
First Posted : October 7, 2008
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Coarctation of the Aorta||Drug: atorvastatin Drug: Sugar pill||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Statins on Endothelial Function in Patients With Coarctation of the Aorta|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
U.S. FDA Resources
Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks. Brachial artery assessment will be performed before and after each 12 week period on therapy.
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)
Other Name: Lipitor
Placebo Comparator: sugar pill
See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
Drug: Sugar pill
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).
Other Name: placebo
- Pre-post Change in Brachial Artery Reactivity [ Time Frame: Baseline, 12 weeks ]Brachial artery reactivity was assessed by Flow-mediated dilatation (FMD), performed before and after the 12 week period on therapy. FMD uses high-frequency ultrasound measurement of changes in brachial artery diameter after a 5-minute blood pressure cuff arterial occlusion. Brachial artery reactivity has been shown to predict long-term cardiovascular events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767572
|United States, California|
|UCSF Medical Center, 505 Parnassus Ave|
|San Francisco, California, United States, 94143|