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Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes

NCT ID: NCT00520585

Last Updated: 2007-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-11-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Heterogeneity of Cardiomyocytes Repolarisation Autonomic Changes of Cardiomyocytes Repolarisation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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atorvastatin

atorvastatin 20 mg once vs. atorvastatin 80 mg once vs. placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Masaryk University

OTHER

Sponsor Role lead

Principal Investigators

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Ondrej Toman, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Brno, Department of Cardiology, Brno, Czech Republic

Central Contacts

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Ondrej Toman, MD

Role: CONTACT

[email protected]
+420532232651

Other Identifiers

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CS-15-11-2006

Identifier Type: -

Identifier Source: org_study_id