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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by AORTICA Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
AORTICA Group
ClinicalTrials.gov Identifier:
NCT00404287
First received: November 27, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Aortic Valve Stenosis
 Drug: Fluvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AORTICA Group:

Primary Outcome Measures:
  • To study changes in CRP (mg/dL) concentration at the end of the study (12 months)

Secondary Outcome Measures:
  • To study changes in other inflammatory biomarkers (specify in the protocol) at the end of the study (12 months)
  • To study changes in these biomarkers in the different grades of aortic stenosis at the end of the study (12 months)
  • To study changes change in aortic valve area and medium aortic transvalvular gradient at the end of the study (12 months)
  • To study the safety and tolerability of fluvastatin in patients with aortic stenosis.

Estimated Enrollment: 164
Study Start Date: October 2006
Estimated Study Completion Date: November 2008
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404287

Contacts
Contact: Pedro L Sanchez, MD, PhD 34-637971999 pedrolsanchez@secardiologia.es
Contact: Javier Martin-Moreiras, MD 34-629253116 jmmoreiras@yahoo.es

Locations
Spain
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37002
Contact: Pedro L Sanchez, MD, PhD     34-637971999     pedrolsanchez@secardiologia.es    
Contact: Javier Martin-Moreiras, MD, PhD         jmmoreiras@yahoo.es    
Principal Investigator: Candido Martin-Luengo, MD, PhD            
Principal Investigator: Pedro L Sanchez, MD, PhD            
Sponsors and Collaborators
AORTICA Group
Investigators
Principal Investigator: Pedro L Sanchez, MD, PhD Hospital Universitario Gregorio Marañón de Madrid
Study Chair: Candido Martin-Luengo, MD, PhD Hospital Universitario de Salamanca
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00404287     History of Changes
Other Study ID Numbers: CXUO320BES04, EudraCT number 2005-003666-42
Study First Received: November 27, 2006
Last Updated: November 27, 2006
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by AORTICA Group:
C reactive protein
Inflammation
Aortic valve stenosis
progression

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical
Fluvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013