Statin Therapy in Asymptomatic Aortic Stenosis

NCT00176410 | Unknown Phase 2

• 1 other identifier: Leipzig aortic valve study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

aortic valve stenosis; statin therapy

Outcome Measures

Primary Outcomes (3)

• Progression of calcified aortic stenosis measured by:

  24 months

• Transthoracic echocardiography (P max/ mean; V max; AVA)

  24 months

• Catheterization (peak to peak gradient, LV-function, compliance)

  24 months

Secondary Outcomes (1)

• Number of cardiovascular events

  24 months

Interventions

fluvastatin DRUG

40mg fluvastatin daily

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leipzig: lead
• Novartis: collaborator

Study Sites (1)

University of Leipzig - Heart Center

Leipzig, Saxony, 04289, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Gerhard Schuler, Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Walther, MD

CONTACT

xx49-341-8651428; waltherc@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2003
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 14, 2010

Record last verified: 2006-09

Locations

DE (1)