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Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes (ATORVA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by Masaryk University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520585
First Posted: August 24, 2007
Last Update Posted: August 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Masaryk University
  Purpose

The aim of this study is to evaluate influence of atorvastin on the repolarisation phase of cardiomyocytes. If there is any, it could be a part of positive "non-lipid" effect of statins in therapy of ischaemic heart disease.

Study hypothesis: atorvastin will decrease heterogeneity of repolarisation of cardiomyocytes in comparison with placebo


Condition Intervention
Heterogeneity of Cardiomyocytes Repolarisation Autonomic Changes of Cardiomyocytes Repolarisation Drug: atorvastatin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes

Resource links provided by NLM:


Further study details as provided by Masaryk University:

Study Start Date: August 2007
Estimated Study Completion Date: November 2007
Intervention Details:
    Drug: atorvastatin
    atorvastatin 20 mg once vs. atorvastatin 80 mg once vs. placebo
Detailed Description:
The group will consist of 40 healthy volunteers. The study will be mono-centric. The repolarisation phase of cardiomyocytes will be evaluated using long - term 12-lead digital ECG monitoring. There will be 3 single ECG recordings - randomly after 20 mg of atorvastin, 80 mg of atorvastatin and placebo, respectively.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • signed informed consent
  • age 18 - 45 years

Exclusion Criteria:

  • no chronic active disease
  • no concomitant pharmacotherapy, excluding hormonal contraception
  • abnormal ECG, echocardiography, laboratory findings
  • known hypersensitivity or myopathy due o statin
  • pregnancy, lactation, breast implants
  • skin disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520585


Contacts
Contact: Ondrej Toman, MD +420532232651 ondrej.toman@atlas.cz

Sponsors and Collaborators
Masaryk University
Investigators
Principal Investigator: Ondrej Toman, MD University Hospital Brno, Department of Cardiology, Brno, Czech Republic
  More Information

ClinicalTrials.gov Identifier: NCT00520585     History of Changes
Other Study ID Numbers: CS-15-11-2006
First Submitted: August 22, 2007
First Posted: August 24, 2007
Last Update Posted: August 24, 2007
Last Verified: August 2007

Keywords provided by Masaryk University:
atorvastatin
repolarisation
cardiomyocytes

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors