NCT00404287

Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis.

Double Blind Randomized Phase IV Clinical Trial to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in the Haemodynamic Progression of Degenerative Aortic Stenosis. The AORTICA 1 Study.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: AORTICA Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Atherosclerosis and aortic stenosis share inflammatory etiopathogenic characteristics in common. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease.

Detailed description

This study will be a prospective, phase IV-III, randomized, double blinded, active controlled study, to evaluate the efficacy of fluvastatin on inflammatory markers in the haemodynamic progression of degenerative aortic stenosis. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease. Eligible patients with degenerative aortic stenosis will be randomized 1:1 to fluvastatin 80 mg once daily or placebo. The treatment should be continued until the study end (12 months). Follow up investigations will be performed after 3 months and at the end of the study (12 months).

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DRUG	Fluvastatin

Timeline

• Start date: 2006-10-01
• Primary completion: 2014-11-01
• Completion: 2018-01-01
• First posted: 2006-11-28
• Last updated: 2019-06-07

Locations

1 site across 1 country: Spain