Clinical trial NCT00590135: The Effect of Lipitor on Aortic Stenosis
Official title: The Effect of Statin Therapy (Atorvastatin) on the Progression of Calcific Valvular Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Aortic Valve Stenosis
Keywords: calcific aortic valve stenosis
echocardiography, transthoracic
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-01-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Aortic Stenosis
timeFrame: 2 years
Secondary outcomes:
measure: Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls
timeFrame: 2 years
measure: Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls
timeFrame: 2 years
measure: Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group
timeFrame: 2 years
measure: Change in Mean and Peak Gradients Across the Aortic Valve as Measured by TEE in the Treated Group Compared to Historical Control Group.
timeFrame: 2 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Brian P Griffin, M.D.
role: PRINCIPAL_INVESTIGATOR
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