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
100
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