The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle

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Brief Title

The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle

Official Title

The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle in Patients With Dilated Cardiomyopathy

Brief Summary

      The aim of the study was to assess of the influence of atorvastatin on selected indicators of
      an inflammatory condition, function of the left ventricle and factors affecting the
      occurrence of undesired events like rehospitalizations and mortality in patients with dilated
      cardiomyopathy.
    



Study Type

Observational


Primary Outcome

left ventricular function

Secondary Outcome

 mortality

Condition

Dilated Cardiomyopathy

Intervention

Tulip

Study Arms / Comparison Groups

 Atorvastatin
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug


Start Date

February 2007

Completion Date

February 2009

Primary Completion Date

December 2008

Eligibility Criteria

        Inclusion Criteria:

          -  patients 18 years old or older

          -  patients who signed informed consent

          -  patients with dilated cardiomyopathy (according ESC 2007)

          -  patients who had no significant coronary artery stenoses >30% on cardiac
             catheterization

        Exclusion Criteria:

          -  BP ≥140/90 lub <90/60

          -  congenital heart disease

          -  acquired valvular disease except for mitral incompetence secondary to left ventricular
             dilatation

          -  New York Heart Association (NYHA) functional class IV

          -  statin treatment

          -  preserved hyperactivity of aminotransferases with unexplained etiology,

          -  muscle disorders which might cause drug-induced myopathy,

          -  uncontrolled diabetes,

          -  liver diseases,

          -  creatinine level > 2 mg/dl and/or GFR<30ml/min,

          -  abuse of alcohol or drugs,

          -  chronic inflammatory diseases,

          -  pregnancy or lactation,

          -  severe hypothyroidism,

          -  immunosuppressive treatment,

          -  operation or severe injury during last month

          -  vaccination during last 3 months

          -  heart stimulation device or implantable cardioverter defibrillator

          -  or who didn't write conscious consent
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Agata Bielecka-Dabrowa, PhD, , 



Administrative Informations


NCT ID

NCT01015144

Organization ID

502-11-585



Study Sponsor

Medical Universtity of Lodz


Study Sponsor

Agata Bielecka-Dabrowa, PhD, Principal Investigator, Department of Hypertension UM Lodz


Verification Date

November 2009