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

Primary Purpose

Aortic Valve Stenosis

Status

Terminated

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Fluvastatin

About this trial

This is an interventional prevention trial for Aortic Valve Stenosis focused on measuring C reactive protein, Inflammation, Aortic valve stenosis, progression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Symptomatic patients caused by aortic stenosis.
Patients on statins anytime in the year before inclusion.
Patients diagnosed of dyslipidemia requiring statins.
Temperature ³37,8 ºC in the week before inclusion.
Any cardiovascular event succeeding in the three months before inclusion
Known thyrotoxicosis
Renal failure requiring hemodialysis
Any inflammatory noncardiac diseases or other reasons known to influence the study biomarkers concentrations.
Any surgery succeeding in the three months before inclusion.
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

Sites / Locations

Hospital Universitario de Salamanca

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

fluvastatin

placebo

Arm Description

fluvastatin 80 mg

Outcomes

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.

Full Information

NCT ID

NCT00404287

First Posted

November 27, 2006

Last Updated

June 6, 2019

Sponsor

AORTICA Group

1. Study Identification

Unique Protocol Identification Number

NCT00404287

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

Funding not enough to complete the study

Study Start Date

October 1, 2006 (Actual)

Primary Completion Date

November 1, 2014 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

AORTICA Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

Keywords

C reactive protein, Inflammation, Aortic valve stenosis, progression

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

164 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fluvastatin

Arm Type

Active Comparator

Arm Description

fluvastatin 80 mg

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Fluvastatin

Primary Outcome Measure Information:

Title

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Time Frame

12 months

Title

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

Title

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

Title

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Symptomatic patients caused by aortic stenosis. Patients on statins anytime in the year before inclusion. Patients diagnosed of dyslipidemia requiring statins. Temperature ³37,8 ºC in the week before inclusion. Any cardiovascular event succeeding in the three months before inclusion Known thyrotoxicosis Renal failure requiring hemodialysis Any inflammatory noncardiac diseases or other reasons known to influence the study biomarkers concentrations. Any surgery succeeding in the three months before inclusion. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pedro L Sanchez, MD, PhD

Organizational Affiliation

Hospital Universitario Gregorio Marañón de Madrid

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Candido Martin-Luengo, MD, PhD

Organizational Affiliation

University of Salamanca

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital Universitario de Salamanca

City

Salamanca

ZIP/Postal Code

37002

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16774687

Citation

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.

Results Reference

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PubMed Identifier

16377290

Citation

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.

Results Reference

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Learn more about this trial

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

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