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

This study has been completed.

Sponsor:

Information provided by:

Medical Universtity of Lodz

ClinicalTrials.gov Identifier:

NCT01015144

First received: November 17, 2009

Last updated: NA

Last verified: November 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 17, 2009

Last Updated Date

November 17, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

left ventricular function [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

blood68

Sampling Method

Probability Sample

Study Population

Patients with dilated cardiomyopathy (according ESC 2007) with EF≤40% as documented by echocardiography were included.

Condition ^ICMJE

Dilated Cardiomyopathy

Intervention ^ICMJE

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.

Study Group/Cohort (s)

Atorvastatin
Intervention: Drug: Tulip
No statin

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

February 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01015144

Other Study ID Numbers ^ICMJE

502-11-585

Has Data Monitoring Committee

Yes

Responsible Party

Agata Bielecka-Dąbrowa, UM Lodz

Study Sponsor ^ICMJE

Medical Universtity of Lodz

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Agata Bielecka-Dabrowa, PhD	Department of Hypertension UM Lodz
Study Director:	Maciej Banach, Assoc. Prof.	Department of Hypertension UM Lodz

Information Provided By

Medical Universtity of Lodz

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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