NCT00404287

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2006

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

8.1 years

First QC Date

November 27, 2006

Last Update Submit

June 6, 2019

Conditions

Aortic Valve Stenosis

Keywords

C reactive proteinInflammationAortic valve stenosisprogression

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (4)

  • To study changes in other inflammatory biomarkers (specify in the protocol) at the end of the study (12 months)

    12 months

  • To study changes in these biomarkers in the different grades of aortic stenosis at the end of the study (12 months)

    12 months

  • To study changes change in aortic valve area and medium aortic transvalvular gradient at the end of the study (12 months)

    12 months

  • To study the safety and tolerability of fluvastatin in patients with aortic stenosis.

    12 months

Study Arms (2)

fluvastatin

ACTIVE COMPARATOR

fluvastatin 80 mg

Drug: Fluvastatin

placebo

PLACEBO COMPARATOR
Drug: Fluvastatin

Interventions

FluvastatinDRUG
fluvastatinplacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Symptomatic patients caused by aortic stenosis.
  • Patients diagnosed of dyslipidemia requiring statins.
  • Known thyrotoxicosis
  • Renal failure requiring hemodialysis
  • Any inflammatory noncardiac diseases or other reasons known to influence the study biomarkers concentrations.
  • Patients with any hepatopathy that in the view of the investigator prohibits participation in the study.
  • Patients with known muscular disease.
  • Patients with any severe medical condition that in the view of the investigator prohibits participation in the study
  • Use of corticoids, immunosuppressors or non steroid drugs.
  • Any known sensitivity to study drug (fluvastatin) or class of study drug.
  • Patients participating in any study in the last year.
  • Women of childbearing potential not using the contraception method(s) specified in this study, suspicion of pregnancy, as well as women who are breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Salamanca

Salamanca, 37002, Spain

Location

Related Publications (2)

  • 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.

    PMID: 16774687BACKGROUND

  • 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.

    PMID: 16377290BACKGROUND

MeSH Terms

Conditions

Aortic Valve StenosisInflammationDisease Progression

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Pedro L Sanchez, MD, PhD

    Hospital Universitario Gregorio Marañón de Madrid

    PRINCIPAL INVESTIGATOR

  • Candido Martin-Luengo, MD, PhD

    University of Salamanca

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 28, 2006

Study Start

October 1, 2006

Primary Completion

November 1, 2014

Study Completion

January 1, 2018

Last Updated

June 7, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)