Statin Therapy in Asymptomatic Aortic Stenosis

Aortic Valve Stenosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00176410
• Other study ID #: Leipzig aortic valve study
• Status: Recruiting
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: January 13, 2010
• Start date: January 2003
• Est. completion date: December 2009

Study information

• Verified date: September 2006
• Source: University of Leipzig
• Contact: Claudia Walther, MD
• Phone: xx49-341-8651428
• Email: waltherc[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Drug:
• fluvastatin
40mg fluvastatin daily

Locations

Country	Name	City	State
Germany	University of Leipzig - Heart Center	Leipzig	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of calcified aortic stenosis measured by:		24 months	No
Primary	Transthoracic echocardiography (P max/ mean; V max; AVA)		24 months	No
Primary	Catheterization (peak to peak gradient, LV-function, compliance)		24 months	No
Secondary	Number of cardiovascular events		24 months	No