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

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ClinicalTrials.gov Identifier: NCT00520585
Recruitment Status : Unknown
Verified August 2007 by Masaryk University.
Recruitment status was:  Not yet recruiting
First Posted : August 24, 2007
Last Update Posted : August 24, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Heterogeneity of Cardiomyocytes Repolarisation Autonomic Changes of Cardiomyocytes Repolarisation Drug: atorvastatin

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.

Study Design

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : August 2007
Estimated Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: atorvastatin
    atorvastatin 20 mg once vs. atorvastatin 80 mg once vs. placebo

Outcome Measures

Eligibility Criteria

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 Posted: August 24, 2007    Key Record Dates
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