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Statin Therapy in Asymptomatic Aortic Stenosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00176410
First received: September 13, 2005
Last updated: January 13, 2010
Last verified: September 2006
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Progression of calcified aortic stenosis measured by: [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Transthoracic echocardiography (P max/ mean; V max; AVA) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Catheterization (peak to peak gradient, LV-function, compliance) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of cardiovascular events [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: January 13, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical
Fluvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013