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

Sponsored by:	AORTICA Group
Information provided by:	AORTICA Group
ClinicalTrials.gov Identifier:	NCT00404287

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

Drug Information available for: Fluvastatin

U.S. FDA Resources

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)

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.

Estimated Enrollment:	164
Study Start Date:	October 2006
Estimated Study Completion Date:	November 2008

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:

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

Contacts and Locations

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

Contacts

Contact: Pedro L Sanchez, MD, PhD	34-637971999	pedrolsanchez@secardiologia.es
Contact: Javier Martin-Moreiras, MD	34-629253116	jmmoreiras@yahoo.es

Locations

Spain
Hospital Universitario de Salamanca	Recruiting
Salamanca, Spain, 37002
Contact: Pedro L Sanchez, MD, PhD 34-637971999 pedrolsanchez@secardiologia.es
Contact: Javier Martin-Moreiras, MD, PhD jmmoreiras@yahoo.es
Principal Investigator: Candido Martin-Luengo, MD, PhD
Principal Investigator: Pedro L Sanchez, MD, PhD

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:

Sanchez PL, Mazzone A. C-reactive protein in degenerative aortic valve stenosis. Cardiovasc Ultrasound. 2006 Jun 14;4:24. Review.

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. Epub 2005 Nov 10.

Study ID Numbers:	CXUO320BES04, EudraCT number 2005-003666-42
Study First Received:	November 27, 2006
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00404287 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by AORTICA Group:

C reactive protein
Inflammation
Aortic valve stenosis
progression

Study placed in the following topic categories:

Antimetabolites
Pathological Conditions, Anatomical
Heart Diseases
Antilipemic Agents
Disease Progression
Constriction, Pathologic

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Aortic Valve Stenosis
Fluvastatin
Heart Valve Diseases
Inflammation

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Antimetabolites
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Constriction, Pathologic
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Fluvastatin
Heart Valve Diseases
Therapeutic Uses
Cardiovascular Diseases
Aortic Valve Stenosis
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 03, 2009