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Completed

NCT Number: NCT01015144

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

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.

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Key information

Conditions

Dilated Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Failure Inflammation Laminopathies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tulip

Drug

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.

Primary outcomes

  1. left ventricular function

    Time frame: 2 months

Secondary outcomes

  1. mortality

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Nov 18, 2009
Registry last updated
Nov 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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