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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01015144
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : November 18, 2009
Information provided by:
Medical Universtity of Lodz

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.

Condition or disease Intervention/treatment
Dilated Cardiomyopathy Drug: Tulip

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Study Type : Observational
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle in Patients With Dilated Cardiomyopathy
Study Start Date : February 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

Group/Cohort Intervention/treatment
Atorvastatin Drug: Tulip
Patients were divided into two groups: A, who were administered atorvastatin 40 mg daily for two months and 10 mg for next 4 months; and group B, 4 who were treated according to current guidelines without statin therapy.

No statin

Primary Outcome Measures :
  1. left ventricular function [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with dilated cardiomyopathy (according ESC 2007) with EF≤40% as documented by echocardiography were included.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01015144

Sponsors and Collaborators
Medical Universtity of Lodz
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Principal Investigator: Agata Bielecka-Dabrowa, PhD Department of Hypertension UM Lodz
Study Director: Maciej Banach, Assoc. Prof. Department of Hypertension UM Lodz
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Agata Bielecka-Dąbrowa, UM Lodz Identifier: NCT01015144    
Other Study ID Numbers: 502-11-585
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: November 18, 2009
Last Verified: November 2009
Keywords provided by Medical Universtity of Lodz:
dilated cardiomyopathy
heart failure
Additional relevant MeSH terms:
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Cardiomyopathy, Dilated
Pathologic Processes
Heart Diseases
Cardiovascular Diseases