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ATORVA: Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes

Sponsor
Masaryk University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00520585
Collaborator
(none)
3
Duration (Months)

Study Details

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 Phase
N/A

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
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 :
Aug 1, 2007
Anticipated Study Completion Date :
Nov 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Masaryk University

    Investigators

    • Principal Investigator: Ondrej Toman, MD, University Hospital Brno, Department of Cardiology, Brno, Czech Republic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00520585
    Other Study ID Numbers:
    • CS-15-11-2006
    First Posted:
    Aug 24, 2007
    Last Update Posted:
    Aug 24, 2007
    Last Verified:
    Aug 1, 2007
    Keywords provided by , ,
    atorvastatin
    repolarisation
    cardiomyocytes
    Additional relevant MeSH terms:
    Atorvastatin

    Study Results

    No Results Posted as of Aug 24, 2007