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TerminatedNCT00404287Updated Jun 7, 2019

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

A Phase 4 interventional study of Fluvastatin in Aortic Valve Stenosis, sponsored by AORTICA Group. Terminated at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-07.

Sponsored by AORTICA Group · Phase 4, Interventional, and Prevention

Why this study was terminated
Funding not enough to complete the study
Phase
Phase 4
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Aortic Valve Stenosis

Keywords

  • C reactive protein
  • Inflammation
  • Aortic valve stenosis
  • progression
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In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 164 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

AORTICA Group is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
164 participants (actual)

Study arms

  • Active comparator
    fluvastatin

    fluvastatin 80 mg

    Drug: Fluvastatin

  • Placebo comparator
    placebo

    Drug: Fluvastatin

Interventions

  • DrugFluvastatin
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What researchers measure

Primary outcomes

  1. To study changes in CRP (mg/dL) concentration at the end of the study (12 months)

    Time frame: 12 months

Secondary outcomes

  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

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Study locations

1 site
  • Hospital Universitario de Salamanca
    Salamanca, 37002, Spain
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References and documents

Publications

  • 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. PubMed 16774687 ↗
  • 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. PubMed 16377290 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00404287
Lead sponsor
AORTICA Group
Responsible party
Pedro L Sanchez (MD, PhD, AORTICA Group) — Principal investigator
First posted
Nov 28, 2006
Start date
Oct 1, 2006
Primary completion
Nov 1, 2014
Completion
Jan 2018
Last update
Jun 7, 2019

Study contacts

Pedro L Sanchez, MD, PhD
principal investigator · Hospital Universitario Gregorio Marañón de Madrid
Candido Martin-Luengo, MD, PhD
study chair · University of Salamanca

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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