Status:
UNKNOWN
Statin Therapy in Asymptomatic Aortic Stenosis
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
Novartis
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
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 typica...
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 w...
Eligibility Criteria
Inclusion
- Age ≥ 21 years
- Mild to moderate aortic stenosis
- No symptoms caused by aortic stenosis
- Written informed consent to participate in the study
- Aortic valve leaflet thickening with reduced systolic opening
- Reduced aortic valve area \> 0,8 cm2 and \< 1,5 cm2
- Maximum aortic jet velocity at rest \> 2,5 m/s
Exclusion
- Symptoms caused by aortic stenosis
- Aortic valve area \< 0,7 cm2
- Severe aortic regurgitation
- Reduced left ventricular ejection fraction (\< 50%)
- Any valve disease with indication for surgery
- Coronary artery disease
- Therapy refractory arterial hypertension
- Comorbid noncardiac diseases or other reasons which make a regular follow-up impossible
- Other indication for treatment with statins
- Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
- Known sensitivity to study drug(s) or class of study drug(s)
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
- Use of any other investigational agent in the last 30 days
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00176410
Start Date
January 1 2003
End Date
December 1 2009
Last Update
January 14 2010
Active Locations (1)
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1
University of Leipzig - Heart Center
Leipzig, Saxony, Germany, 04289