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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
  Purpose

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 Intervention
Dilated Cardiomyopathy
 Drug: Tulip

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • left ventricular function [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood68


Study Start Date: February 2007
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015144

Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Principal Investigator: Agata Bielecka-Dabrowa, PhD Department of Hypertension UM Lodz
Study Director: Maciej Banach, Assoc. Prof. Department of Hypertension UM Lodz
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Agata Bielecka-Dąbrowa, UM Lodz
ClinicalTrials.gov Identifier: NCT01015144     History of Changes
Other Study ID Numbers: 502-11-585
Study First Received: November 17, 2009
Last Updated: November 17, 2009
Health Authority: Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Medical Universtity of Lodz:
atorvastatin
dilated cardiomyopathy
heart failure
inflammation

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Inflammation
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013