Back to resultsStatin Therapy in Asymptomatic Aortic Stenosis
Primary Purpose
Aortic Valve Stenosis
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
fluvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring aortic valve stenosis, statin therapy
Eligibility Criteria
Inclusion Criteria: Age ≥ 21 years Mild to moderate aortic stenosis No symptoms caused by aortic stenosis Written informed consent to participate in the study Aortic valve leaflet thickening with reduced systolic opening Reduced aortic valve area > 0,8 cm2 and < 1,5 cm2 Maximum aortic jet velocity at rest > 2,5 m/s Exclusion Criteria: Symptoms caused by aortic stenosis Aortic valve area < 0,7 cm2 Severe aortic regurgitation Reduced left ventricular ejection fraction (< 50%) Any valve disease with indication for surgery Coronary artery disease Therapy refractory arterial hypertension Comorbid noncardiac diseases or other reasons which make a regular follow-up impossible Other indication for treatment with statins Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding Known sensitivity to study drug(s) or class of study drug(s) Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required) Use of any other investigational agent in the last 30 days
Sites / Locations
- University of Leipzig - Heart CenterRecruiting
Outcomes
Primary Outcome Measures
Progression of calcified aortic stenosis measured by:
Transthoracic echocardiography (P max/ mean; V max; AVA)
Catheterization (peak to peak gradient, LV-function, compliance)
Secondary Outcome Measures
Number of cardiovascular events
Full Information
NCT ID
NCT00176410
First Posted
September 13, 2005
Last Updated
January 13, 2010
Sponsor
University of Leipzig
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00176410
Brief Title
Statin Therapy in Asymptomatic Aortic Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Leipzig
Collaborators
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
aortic valve stenosis, statin therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fluvastatin
Intervention Description
40mg fluvastatin daily
Primary Outcome Measure Information:
Title
Progression of calcified aortic stenosis measured by:
Time Frame
24 months
Title
Transthoracic echocardiography (P max/ mean; V max; AVA)
Time Frame
24 months
Title
Catheterization (peak to peak gradient, LV-function, compliance)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of cardiovascular events
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 21 years
Mild to moderate aortic stenosis
No symptoms caused by aortic stenosis
Written informed consent to participate in the study
Aortic valve leaflet thickening with reduced systolic opening
Reduced aortic valve area > 0,8 cm2 and < 1,5 cm2
Maximum aortic jet velocity at rest > 2,5 m/s
Exclusion Criteria:
Symptoms caused by aortic stenosis
Aortic valve area < 0,7 cm2
Severe aortic regurgitation
Reduced left ventricular ejection fraction (< 50%)
Any valve disease with indication for surgery
Coronary artery disease
Therapy refractory arterial hypertension
Comorbid noncardiac diseases or other reasons which make a regular follow-up impossible
Other indication for treatment with statins
Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
Known sensitivity to study drug(s) or class of study drug(s)
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
Use of any other investigational agent in the last 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Walther, MD
Phone
xx49-341-8651428
Email
waltherc@medizin.uni-leipzig.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Schuler, Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig - Heart Center
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Walther, MD
Phone
xx49-341-8651428
Email
waltherc@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Claudia A Walther, MD
12. IPD Sharing Statement
Learn more about this trial
Statin Therapy in Asymptomatic Aortic Stenosis
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