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

NCT ID: NCT01015144

Last Updated: 2009-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-02-28

Brief Summary

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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

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Conditions

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Dilated Cardiomyopathy

Keywords

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atorvastatin dilated cardiomyopathy heart failure inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Atorvastatin

Tulip

Intervention Type 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.

No statin

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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UM Lodz

Principal Investigators

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Agata Bielecka-Dabrowa, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Hypertension UM Lodz

Maciej Banach, Assoc. Prof.

Role: STUDY_DIRECTOR

Department of Hypertension UM Lodz

References

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

Reference Type BACKGROUND
PMID: 18698552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18350717 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20178563 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19946241 (View on PubMed)

Other Identifiers

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502-11-585

Identifier Type: -

Identifier Source: org_study_id