Clinical trial NCT00176410: Statin Therapy in Asymptomatic Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Aortic Valve Stenosis
Keywords: aortic valve stenosis
statin therapy
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression of calcified aortic stenosis measured by:
timeFrame: 24 months
measure: Transthoracic echocardiography (P max/ mean; V max; AVA)
timeFrame: 24 months
measure: Catheterization (peak to peak gradient, LV-function, compliance)
timeFrame: 24 months
Secondary outcomes:
measure: Number of cardiovascular events
timeFrame: 24 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig - Heart Center
state: Saxony
Study officials:
name: Gerhard Schuler, Professor
role: PRINCIPAL_INVESTIGATOR
References: