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

Dilated Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015144
• Other study ID #: 502-11-585
• Status: Completed
• Phase: N/A
• First received: November 17, 2009
• Last updated: November 17, 2009
• Start date: February 2007
• Est. completion date: February 2009

Study information

• Verified date: November 2009
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Inflammation

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

References & Publications (2)

Bielecka-Dabrowa A, Wierzbicka M, Dabrowa M, Goch A. New methods in laboratory diagnostics of dilated cardiomyopathy. Cardiol J. 2008;15(4):388-95. Review. — View 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. Review. Polish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular function		2 months	No
Secondary	mortality		6 months	No