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Statins and Endothelial Function in Patients With Coarctation of the Aorta

Primary Purpose

Coarctation of the Aorta

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
atorvastatin
Sugar pill
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coarctation of the Aorta focused on measuring Coarctation of the aorta, cross over design, atorvastatin, endothelial function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Medical Center, 505 Parnassus Ave

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

atorvastatin

sugar pill

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2008
Last Updated
October 11, 2013
Sponsor
University of California, San Francisco
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT00767572
Brief Title
Statins and Endothelial Function in Patients With Coarctation of the Aorta
Official Title
Effects of Statins on Endothelial Function in Patients With Coarctation of the Aorta
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coarctation of the Aorta
Keywords
Coarctation of the aorta, cross over design, atorvastatin, endothelial function

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
atorvastatin
Arm Type
Experimental
Arm Description
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.
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Other Intervention Name(s)
Lipitor
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)
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Other Intervention Name(s)
placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pre-post Change in Brachial Artery Reactivity
Description
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.
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UCSF Medical Center, 505 Parnassus Ave
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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Statins and Endothelial Function in Patients With Coarctation of the Aorta

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