Clinical trial NCT01015144: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dilated Cardiomyopathy
Keywords: atorvastatin
dilated cardiomyopathy
heart failure
inflammation
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2009-11-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with dilated cardiomyopathy (according ESC 2007) with EF≤40% as documented by echocardiography were included.

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.


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

Primary outcomes:
measure: left ventricular function
timeFrame: 2 months
Secondary outcomes:
measure: mortality
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Hypertension UM Lodz
name: Agata Bielecka-Dabrowa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Hypertension UM Lodz
name: Maciej Banach, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: Bielecka-Dabrowa A, Wierzbicka M, Dabrowa M, Goch A. New methods in laboratory diagnostics of dilated cardiomyopathy. Cardiol J. 2008;15(4):388-95.
citation: Bielecka-Dabrowa A, Wierzbicka M, Goch JH. [Proinflammatory cytokines in cardiovascular diseases as potential therapeutic target]. Wiad Lek. 2007;60(9-10):433-8. Polish.
citation: Bielecka-Dabrowa A, Goch JH, Rysz J, Maciejewski M, Desai R, Aronow WS, Banach M. Influence of co-existing atrial fibrillation on the efficacy of atorvastatin treatment in patients with dilated cardiomyopathy: a pilot study. Lipids Health Dis. 2010 Feb 23;9:21. doi: 10.1186/1476-511X-9-21.
citation: Bielecka-Dabrowa A, Goch JH, Mikhailidis DP, Rysz J, Maciejewski M, Banach M. The influence of atorvastatin on parameters of inflammation and function of the left ventricle in patients with dilated cardiomyopathy. Med Sci Monit. 2009 Dec;15(12):MS12-23.