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Statin Therapy in Asymptomatic Aortic Stenosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by University of Leipzig.
Recruitment status was:  Recruiting
Information provided by:
University of Leipzig Identifier:
First received: September 13, 2005
Last updated: January 13, 2010
Last verified: September 2006
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 Intervention Phase
Aortic Valve Stenosis Drug: fluvastatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Leipzig:

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

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

Estimated Enrollment: 100
Study Start Date: January 2003
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fluvastatin
    40mg fluvastatin daily
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.

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00176410

Contact: Claudia Walther, MD xx49-341-8651428

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
Principal Investigator: Gerhard Schuler, Professor
  More Information

Responsible Party: Claudia Walther, University of Leipzig, Department of Cardiology Identifier: NCT00176410     History of Changes
Other Study ID Numbers: Leipzig aortic valve study
Study First Received: September 13, 2005
Last Updated: January 13, 2010

Keywords provided by University of Leipzig:
aortic valve stenosis
statin therapy

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on September 21, 2017