Statin Therapy in Asymptomatic Aortic Stenosis

Phase 2

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT00176410
• Lead Sponsor: University of Leipzig

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 Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Status Verified: 2006-09
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression of calcified aortic stenosis measured by:	24 months
Transthoracic echocardiography (P max/ mean; V max; AVA)	24 months
Catheterization (peak to peak gradient, LV-function, compliance)	24 months

Secondary Outcome Measures

Name	Time	Method
Number of cardiovascular events	24 months

Trial Locations

Locations (1)

University of Leipzig - Heart Center; 🇩🇪 Leipzig, Saxony, Germany