The Effect of Lipitor on Aortic Stenosis

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

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