Statins and Endothelial Function in Patients With Coarctation of the Aorta

Coarctation of the Aorta Clinical Trial

Official title:

Effects of Statins on Endothelial Function in Patients With Coarctation of the Aorta

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00767572
• Other study ID #: H7151-32792-01
• Status: Terminated
• Phase: Phase 4
• First received: September 24, 2008
• Last updated: October 11, 2013
• Start date: August 2008
• Est. completion date: July 2010

Study information

• Verified date: October 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aortic Coarctation
• Coarctation of the Aorta

Intervention

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)
• 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).

Locations

Country	Name	City	State
United States	UCSF Medical Center, 505 Parnassus Ave	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-post Change in Brachial Artery Reactivity	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.	Baseline, 12 weeks	No