Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes

Autonomic Changes of Cardiomyocytes Repolarisation Clinical Trial

— ATORVA  

Official title:

Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00520585
• Other study ID #: CS-15-11-2006
• Status: Not yet recruiting
• Phase: N/A
• First received: August 22, 2007
• Last updated: August 22, 2007
• Start date: August 2007
• Est. completion date: November 2007

Study information

• Verified date: August 2007
• Source: Masaryk University
• Contact: Ondrej Toman, MD
• Phone: +420532232651
• Email: ondrej.toman[@]atlas.cz
• Is FDA regulated: No
• Health authority: Czech Republic: University Hospital BrnoCzech Republic: Masaryk University Brno
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Autonomic Changes of Cardiomyocytes Repolarisation
• Heterogeneity of Cardiomyocytes Repolarisation

Intervention

Drug:
• atorvastatin
atorvastatin 20 mg once vs. atorvastatin 80 mg once vs. placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk University