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

Masaryk University

Status: Unknown

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

Treatments: Drug: atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00520585

CS-15-11-2006

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind