Statin Therapy in Asymptomatic Aortic Stenosis

NCT ID: NCT00176410

Last Updated: 2010-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2009-12-31

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.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Interventions

fluvastatin

40mg fluvastatin daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

University of Leipzig, Department of Cardiology

Principal Investigators

Gerhard Schuler, Professor

Role: PRINCIPAL_INVESTIGATOR

Locations

University of Leipzig - Heart Center

Leipzig, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Claudia Walther, MD

Role: CONTACT

waltherc@medizin.uni-leipzig.de

xx49-341-8651428

Facility Contacts

Claudia Walther, MD

Role: primary

waltherc@medizin.uni-leipzig.de

xx49-341-8651428

Other Identifiers

Leipzig aortic valve study

Identifier Type: -

Identifier Source: org_study_id