Schuler 2005.

Trial name or title	Statin therapy in asymptomatic aortic stenosis
Methods	Randomised controlled trial. Allocation: Randomised. Endpoint Classification: Efficacy study. Intervention Model: Single‐group assignment. Masking: Double‐blind (participant, investigator, outcomes assessor). Primary Purpose: Treatment. Phase: 2.
Participants	Inclusion Criteria: 1. Age 21 years to 80 years. 2. Gender: both. 3. Mild to moderate aortic stenosis. 4. No symptoms caused by aortic stenosis. 5. Written informed consent to participate in the study. 6. Aortic valve leaflet thickening with reduced systolic opening. 7. Reduced aortic valve area > 0.8 cm2 and < 1.5 cm2. 8. 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.
Interventions	40 mg fluvastatin daily.
Outcomes	Primary outcomes: 1. Progression of calcified aortic stenosis measured by: [ Time Frame: 24 months ] [ Designated as safety issue: No ]. 2. Transthoracic echocardiography (peak max/ mean, velocity max and aortic valve area) [ Time Frame: 24 months ] [ Designated as safety issue: No ]. 3. Catheterisation (peak to peak gradient, left ventricular function and compliance) [ Time Frame: 24 months ] [ Designated as safety issue: No ]. Secondary outcomes: Number of cardiovascular events [ Time Frame: 24 months ] [ Designated as safety issue: No ].
Starting date	January 2003.
Contact information	Claudia Walther, MD. University of Leipzig. Germany. Telephone: xx49‐341‐8651428. E‐mail: waltherc@medizin.uni‐leipzig.de.
Notes	ClinicalTrials.gov Identifier: NCT00176410. The recruitment status of this study is unknown because the information has not been verified recently. First received: September 13, 2005. Last updated: January 13, 2010. Last verified: September 2006.