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

Completed

• Conditions: Dilated Cardiomyopathy
• Interventions: Drug: Tulip

• Registration Number: NCT01015144
• Lead Sponsor: Medical University of Lodz

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 available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2008-12
• Study Completion: 2009-02
• Status Verified: 2009-11
• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Last Update Submitted: 2009-11-17
• Study First Posted: 2009-11-18
• Last Update Posted: 2009-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Tulip	-

Primary Outcome Measures

Name	Time	Method
left ventricular function	2 months

Secondary Outcome Measures

Name	Time	Method
mortality	6 months