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

November 17, 2009 updated by: Medical University of Lodz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atorvastatin
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.
No statin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
left ventricular function
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2009

Last Update Submitted That Met QC Criteria

November 17, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502-11-585

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dilated Cardiomyopathy

Clinical Trials on Tulip

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe