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

This study has been completed.
Sponsor:
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01015144
First received: November 17, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 17, 2009
November 17, 2009
February 2007
December 2008   (final data collection date for primary outcome measure)
left ventricular function [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle
The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle in Patients With Dilated Cardiomyopathy

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood68

Probability Sample

Patients with dilated cardiomyopathy (according ESC 2007) with EF≤40% as documented by echocardiography were included.

Dilated Cardiomyopathy
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.
  • Atorvastatin
    Intervention: Drug: Tulip
  • No statin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
February 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01015144
502-11-585
Yes
Agata Bielecka-Dąbrowa, UM Lodz
Medical Universtity of Lodz
Not Provided
Principal Investigator: Agata Bielecka-Dabrowa, PhD Department of Hypertension UM Lodz
Study Director: Maciej Banach, Assoc. Prof. Department of Hypertension UM Lodz
Medical Universtity of Lodz
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP