Overview

The Effect of Lipitor on Aortic Stenosis

Status:
Terminated
Trial end date:
2010-04-26
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Cleveland Clinic
Collaborator:
Pfizer
Treatments:
Atorvastatin
Atorvastatin Calcium
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)