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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
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of California, San Francisco

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, 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

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 assessment including echocardiography, magnetic resonance imaging or magnetic resonance angiography (MRI/MRA), serum blood samples, brachial artery reactivity testing, and carotid intimal media thickness testing. Once they have completed their baseline testing, they will be randomized to either atorvastatin 80mg or placebo. They will complete 12 weeks of therapy and return at the end of 12 weeks to have a repeat brachial artery study and serum studies. There will then be a four week washout period where they take no medication. They will return for a follow up visit at the end of that four week period for repeat baseline brachial artery testing and serum studies. They then will be assigned to the opposite agent they were on previously (so if they originally were on placebo they switch to atorvastatin and vice versa). They will complete another 12 weeks of therapy and return at the end for a final brachial artery study and blood testing.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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


Arm Intervention/treatment
Experimental: atorvastatin
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.
Drug: atorvastatin
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
United States, California
UCSF Medical Center, 505 Parnassus Ave
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
American Heart Association

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00767572     History of Changes
Other Study ID Numbers: H7151-32792-01
First Posted: October 7, 2008    Key Record Dates
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2013
Last Verified: October 2013

Keywords provided by University of California, San Francisco:
Coarctation of the aorta
cross over design
atorvastatin
endothelial function

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Diseases
Heart Diseases
Aortic Coarctation
Cardiovascular Abnormalities
Congenital Abnormalities
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors