Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes

Not Applicable

• Conditions: Heterogeneity of Cardiomyocytes Repolarisation; Autonomic Changes of Cardiomyocytes Repolarisation

• Registration Number: NCT00520585
• Lead Sponsor: Masaryk University

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

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 Timeline

• Status Verified: 2007-08
• Study Start: 2007-08
• Study First Submitted: 2007-08-22
• Study First Submitted QC: 2007-08-22
• Last Update Submitted: 2007-08-22
• Study First Posted: 2007-08-24
• Last Update Posted: 2007-08-24
• Study Completion: 2007-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER