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

This study has suspended participant recruitment.
(Funding not enough to complete the study)
Sponsor:
Information provided by (Responsible Party):
Pedro L Sanchez, AORTICA Group
ClinicalTrials.gov Identifier:
NCT00404287
First received: November 27, 2006
Last updated: October 13, 2014
Last verified: October 2014
  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 (Subject, Caregiver, Investigator, Outcomes Assessor)
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:


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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study changes in other inflammatory biomarkers (specify in the protocol) at the end of the study (12 months) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To study changes in these biomarkers in the different grades of aortic stenosis at the end of the study (12 months) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To study changes change in aortic valve area and medium aortic transvalvular gradient at the end of the study (12 months) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To study the safety and tolerability of fluvastatin in patients with aortic stenosis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: October 2006
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fluvastatin
fluvastatin 80 mg
Drug: Fluvastatin
Placebo Comparator: placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404287

Locations
Spain
Hospital Universitario de Salamanca
Salamanca, Spain, 37002
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:
Responsible Party: Pedro L Sanchez, MD, PhD, AORTICA Group
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: October 13, 2014
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
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Pathological Conditions, Anatomical
Ventricular Outflow Obstruction
Fluvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014