ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00404287
Recruitment Status : Suspended (Funding not enough to complete the study)
First Posted : November 28, 2006
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Pedro L Sanchez, AORTICA Group

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Drug: Fluvastatin Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Actual Study Start Date : October 1, 2006
Actual Primary Completion Date : November 1, 2014
Estimated Study Completion Date : January 2018


Arm Intervention/treatment
Active Comparator: fluvastatin
fluvastatin 80 mg
Drug: Fluvastatin
Placebo Comparator: placebo Drug: Fluvastatin



Primary Outcome Measures :
  1. To study changes in CRP (mg/dL) concentration at the end of the study (12 months) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To study changes in other inflammatory biomarkers (specify in the protocol) at the end of the study (12 months) [ Time Frame: 12 months ]
  2. 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 ]
  3. 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 ]
  4. To study the safety and tolerability of fluvastatin in patients with aortic stenosis. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 28, 2006    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pedro L Sanchez, AORTICA Group:
C reactive protein
Inflammation
Aortic valve stenosis
progression

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