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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.
 
ClinicalTrials.gov Identifier: NCT01015144
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : November 18, 2009
Sponsor:
Information provided by:
Medical Universtity of Lodz

Tracking Information
First Submitted Date November 17, 2009
First Posted Date November 18, 2009
Last Update Posted Date November 18, 2009
Study Start Date February 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 17, 2009)
left ventricular function [ Time Frame: 2 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 17, 2009)
mortality [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood68
Sampling Method Probability Sample
Study Population Patients with dilated cardiomyopathy (according ESC 2007) with EF≤40% as documented by echocardiography were included.
Condition Dilated Cardiomyopathy
Intervention 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.
Study Groups/Cohorts
  • Atorvastatin
    Intervention: Drug: Tulip
  • No statin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Enrollment Not Provided
Actual Study Completion Date February 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01015144
Other Study ID Numbers 502-11-585
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Agata Bielecka-Dąbrowa, UM Lodz
Study Sponsor Medical Universtity of Lodz
Collaborators Not Provided
Investigators
Principal Investigator: Agata Bielecka-Dabrowa, PhD Department of Hypertension UM Lodz
Study Director: Maciej Banach, Assoc. Prof. Department of Hypertension UM Lodz
PRS Account Medical Universtity of Lodz
Verification Date November 2009