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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176410
First Posted: September 15, 2005
Last Update Posted: January 14, 2010
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.
Collaborator:
Novartis
Information provided by:
University of Leipzig
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00176410


Contacts
Contact: Claudia Walther, MD xx49-341-8651428 waltherc@medizin.uni-leipzig.de

Locations
Germany
University of Leipzig - Heart Center Recruiting
Leipzig, Saxony, Germany, 04289
Contact: Claudia Walther, MD    xx49-341-8651428    waltherc@medizin.uni-leipzig.de   
Sub-Investigator: Claudia A Walther, MD         
Sponsors and Collaborators
University of Leipzig
Novartis
Investigators
Principal Investigator: Gerhard Schuler, Professor
  More Information

Responsible Party: Claudia Walther, University of Leipzig, Department of Cardiology
ClinicalTrials.gov Identifier: NCT00176410     History of Changes
Other Study ID Numbers: Leipzig aortic valve study
First Submitted: September 13, 2005
First Posted: September 15, 2005
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:
Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Fluvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors