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Statin Therapy in Asymptomatic Aortic Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00176410
Recruitment Status : Unknown
Verified September 2006 by University of Leipzig.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : January 14, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Drug: fluvastatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2003
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : December 2009

Intervention Details:
  • Drug: fluvastatin
    40mg fluvastatin daily

Primary Outcome Measures :
  1. Progression of calcified aortic stenosis measured by: [ Time Frame: 24 months ]
  2. Transthoracic echocardiography (P max/ mean; V max; AVA) [ Time Frame: 24 months ]
  3. Catheterization (peak to peak gradient, LV-function, compliance) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Number of cardiovascular events [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00176410

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Contact: Claudia Walther, MD xx49-341-8651428

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University of Leipzig - Heart Center Recruiting
Leipzig, Saxony, Germany, 04289
Contact: Claudia Walther, MD    xx49-341-8651428   
Sub-Investigator: Claudia A Walther, MD         
Sponsors and Collaborators
University of Leipzig
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Principal Investigator: Gerhard Schuler, Professor
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Responsible Party: Claudia Walther, University of Leipzig, Department of Cardiology Identifier: NCT00176410    
Other Study ID Numbers: Leipzig aortic valve study
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: September 2006
Keywords provided by University of Leipzig:
aortic valve stenosis
statin therapy
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction