Statin Therapy in Asymptomatic Aortic Stenosis

Brief Title

Statin Therapy in Asymptomatic Aortic Stenosis

Brief Summary

      There is evidence that the degenerative changes leading to aortic stenosis are caused by a
      chronic inflammatory process. Furthermore the development of aortic stenosis is partially
      dependent on typical cardiovascular risk factors. An inflammatory process as well as those
      risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase
      inhibitors) would be an appealing concept to reduce both those risks for development of
      aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the
      progression of aortic stenosis.

Detailed Description

      This study will be a prospective, double-blind, placebo-controlled, two-armed clinical trial
      trial to test the influence of statin therapy on the progression of calcified aortic stenosis
      in patients with asymptomatic mild to moderate aortic stenosis. After completion of all
      baseline investigations patients will be randomly assigned to the verum group (fluvastatin
      group) or to the control group (placebo group). Patients in the verum group will receive
      fluvastatin in a starting dose of 40 mg per day. The dose should be increased up to 80 mg per
      day. The treatment should be continued until the study end (24 months). Follow up
      investigations will be performed after 6, 12, and 18 months. After 24 months the final
      investigations will be performed.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Progression of calcified aortic stenosis measured by:

Secondary Outcome

 Number of cardiovascular events

Condition

Aortic Valve Stenosis

Intervention

fluvastatin

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

January 2003

Completion Date

December 2009

Primary Completion Date

September 2009

Eligibility Criteria

        Inclusion Criteria:

          1. Age ≥ 21 years

          2. Mild to moderate aortic stenosis

          3. No symptoms caused by aortic stenosis

          4. Written informed consent to participate in the study

          5. Aortic valve leaflet thickening with reduced systolic opening

          6. Reduced aortic valve area > 0,8 cm2 and < 1,5 cm2

          7. Maximum aortic jet velocity at rest > 2,5 m/s

        Exclusion Criteria:

          1. Symptoms caused by aortic stenosis

          2. Aortic valve area < 0,7 cm2

          3. Severe aortic regurgitation

          4. Reduced left ventricular ejection fraction (< 50%)

          5. Any valve disease with indication for surgery

          6. Coronary artery disease

          7. Therapy refractory arterial hypertension

          8. Comorbid noncardiac diseases or other reasons which make a regular follow-up
             impossible

          9. Other indication for treatment with statins

         10. Women of childbearing potential not using the contraception method(s) specified in
             this study (specify), as well as women who are breastfeeding

         11. Known sensitivity to study drug(s) or class of study drug(s)

         12. Patients with severe medical condition(s) that in the view of the investigator
             prohibits participation in the study (specify as required)

         13. Use of any other investigational agent in the last 30 days

Gender

All

Ages

21 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Gerhard Schuler, Professor, xx49-341-8651428, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT00176410

Organization ID

Leipzig aortic valve study

Study Sponsor

University of Leipzig

Collaborators

 Novartis

Study Sponsor

Gerhard Schuler, Professor, Principal Investigator,

Verification Date

September 2006