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.
Overview
- Phase
- Phase 4
- Intervention
- Fluvastatin
- Conditions
- Aortic Valve Stenosis
- Sponsor
- AORTICA Group
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- To study changes in CRP (mg/dL) concentration at the end of the study (12 months)
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief 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).
Investigators
Pedro L Sanchez
MD, PhD
AORTICA Group
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Asymptomatic
- •Aortic stenosis defined as aortic valve leaflet thickening with reduced systolic opening (maximum aortic jet velocity \>2 m/s)
- •Written informed consent to participate in the study
- •Patients capable to follow all conditions along the study.
Exclusion Criteria
- •Symptomatic patients caused by aortic stenosis.
- •Patients on statins anytime in the year before inclusion.
- •Patients diagnosed of dyslipidemia requiring statins.
- •Temperature ³37,8 ºC in the week before inclusion.
- •Any cardiovascular event succeeding in the three months before inclusion
- •Known thyrotoxicosis
- •Renal failure requiring hemodialysis
- •Any inflammatory noncardiac diseases or other reasons known to influence the study biomarkers concentrations.
- •Any surgery succeeding in the three months before inclusion.
- •Patients with any hepatopathy that in the view of the investigator prohibits participation in the study.
Arms & Interventions
fluvastatin
fluvastatin 80 mg
Intervention: Fluvastatin
placebo
Intervention: Fluvastatin
Outcomes
Primary Outcomes
To study changes in CRP (mg/dL) concentration at the end of the study (12 months)
Time Frame: 12 months
Secondary Outcomes
- To study changes in other inflammatory biomarkers (specify in the protocol) at the end of the study (12 months)(12 months)
- To study changes in these biomarkers in the different grades of aortic stenosis at the end of the study (12 months)(12 months)
- To study the safety and tolerability of fluvastatin in patients with aortic stenosis.(12 months)
- To study changes change in aortic valve area and medium aortic transvalvular gradient at the end of the study (12 months)(12 months)