Clinical trial NCT00404287: Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Aortic Valve Stenosis
Keywords: C reactive protein
Inflammation
Aortic valve stenosis
progression
Lead sponsor: AORTICA Group
Sponsor class: OTHER
First posted: 2006-11-28
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Asymptomatic
3. Aortic stenosis defined as aortic valve leaflet thickening with reduced systolic opening (maximum aortic jet velocity \>2 m/s)
4. Written informed consent to participate in the study
5. Patients capable to follow all conditions along the study.

Exclusion Criteria:

1. Symptomatic patients caused by aortic stenosis.
2. Patients on statins anytime in the year before inclusion.
3. Patients diagnosed of dyslipidemia requiring statins.
4. Temperature ³37,8 ºC in the week before inclusion.
5. Any cardiovascular event succeeding in the three months before inclusion
6. Known thyrotoxicosis
7. Renal failure requiring hemodialysis
8. Any inflammatory noncardiac diseases or other reasons known to influence the study biomarkers concentrations.
9. Any surgery succeeding in the three months before inclusion.
10. Patients with any hepatopathy that in the view of the investigator prohibits participation in the study.
11. Patients with known muscular disease.
12. Patients with any severe medical condition that in the view of the investigator prohibits participation in the study
13. Use of corticoids, immunosuppressors or non steroid drugs.
14. Any known sensitivity to study drug (fluvastatin) or class of study drug.
15. Patients participating in any study in the last year.
16. Women of childbearing potential not using the contraception method(s) specified in this study, suspicion of pregnancy, as well as women who are breastfeeding

Primary outcomes:
measure: To study changes in CRP (mg/dL) concentration at the end of the study (12 months)
timeFrame: 12 months
Secondary outcomes:
measure: To study changes in other inflammatory biomarkers (specify in the protocol) at the end of the study (12 months)
timeFrame: 12 months
measure: To study changes in these biomarkers in the different grades of aortic stenosis at the end of the study (12 months)
timeFrame: 12 months
measure: To study changes change in aortic valve area and medium aortic transvalvular gradient at the end of the study (12 months)
timeFrame: 12 months
measure: To study the safety and tolerability of fluvastatin in patients with aortic stenosis.
timeFrame: 12 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
Study officials:
affiliation: Hospital Universitario Gregorio Marañón de Madrid
name: Pedro L Sanchez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Salamanca
name: Candido Martin-Luengo, MD, PhD
role: STUDY_CHAIR
References:
citation: Sanchez PL, Mazzone A. C-reactive protein in degenerative aortic valve stenosis. Cardiovasc Ultrasound. 2006 Jun 14;4:24. doi: 10.1186/1476-7120-4-24.
citation: Sanchez PL, Santos JL, Kaski JC, Cruz I, Arribas A, Villacorta E, Cascon M, Palacios IF, Martin-Luengo C; Grupo AORTICA (Grupo de Estudio de la Estenosis Aortica). Relation of circulating C-reactive protein to progression of aortic valve stenosis. Am J Cardiol. 2006 Jan 1;97(1):90-3. doi: 10.1016/j.amjcard.2005.07.113. Epub 2005 Nov 10.