Brief Title
The Effect of Lipitor on Aortic Stenosis
Official Title
The Effect of Statin Therapy (Atorvastatin) on the Progression of Calcific Valvular Aortic Stenosis
Brief Summary
The purpose of this study is to find out if an approved medicine that is used to lower
cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve
in patients with a condition called aortic stenosis. Patients who have aortic stenosis who
volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a
physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of
the heart) at the start of the study and every 6 months, stopping at 2 years.
Detailed Description
This is a prospective, single-center study assessing the effect of atorvastatin 40 mg/day
(Lipitor, Pfizer) on the progression of calcific aortic stenosis in approximately 70 patients
with mild to moderate calcific AS of a tricuspid or bicuspid aortic valve. As a control
population, published data on historical AS cohorts will be used, employing the accepted rate
of progression of a decrease in aortic valve area of 0.1 cm²/year. Additionally, also for
comparison, we will prospectively study a registry of AS patients who meet our entry criteria
but are either currently already being treated with or refuse to take an HMG-CoA reductase
inhibitor (referred to as the "standard care" group).
All patient visits, laboratory studies, and echocardiograms will be performed at the
Cleveland Clinic Foundation in Cleveland, Ohio with the exception of the 12-week visit ALT
measurement which may be done at the patient's local doctor's office and the results faxed to
Imaging Research. The 12-week follow-up assessment may be completed over the phone to
establish any change in patient status since baseline, study medication compliance,
concomitant medication use and to ascertain whether or not the appropriate laboratory test
was obtained. Over a 2-year period, assessments will be conducted at baseline, 6, 12, 18, and
24 months.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Aortic Stenosis
Secondary Outcome
Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls
Condition
Aortic Valve Stenosis
Intervention
atorvastatin (Lipitor)
Study Arms / Comparison Groups
AORTIC STENOSIS PATIENTS
Description: Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
59
Start Date
August 2000
Completion Date
April 26, 2010
Primary Completion Date
April 26, 2010
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve
- Echocardiographic derived mean pressure gradient >10 mmHg and an aortic valve area of
0.9 to 1.7 cm2 by continuity equation.
- Laboratory evidence of LDL-c>70 mg/dl within 12 months prior to recruitment.
Exclusion Criteria:
- Left ventricular ejection fraction <50%
- Valvular area of 0.9 cm2 and a mean gradient >30 mmHg
- Rheumatic heart disease
- >Moderate (2+) aortic insufficiency
- Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other
HMG-CoA Reductase Inhibitors (statins)
- End-stage renal disease (ESRD)
- History of thoracic radiation
- Unable or unwilling to sign informed consent
- Unable to unwilling to return for follow-up
- Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or
hematological disorders, vasculitis, or any other situation or medical condition that,
in the investigator's opinion, would make survival for the duration of the study
unlikely, or would otherwise interfere with optimal participation in the study or
produce a significant risk to the patient
- Severe pulmonary hypertension (>55 mmHg)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Brian P Griffin, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00590135
Organization ID
IRB 3516
Responsible Party
Sponsor
Study Sponsor
The Cleveland Clinic
Collaborators
Pfizer
Study Sponsor
Brian P Griffin, M.D., Principal Investigator, The Cleveland Clinic
Verification Date
July 2017