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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Masaryk University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Masaryk University
ClinicalTrials.gov Identifier:
NCT00520585
First received: August 22, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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 Intervention
Heterogeneity of Cardiomyocytes Repolarisation
Autonomic Changes of Cardiomyocytes Repolarisation
Drug: atorvastatin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes

Resource links provided by NLM:


Further study details as provided by Masaryk University:

Study Start Date: August 2007
Estimated Study Completion Date: November 2007
Intervention Details:
    Drug: atorvastatin
    atorvastatin 20 mg once vs. atorvastatin 80 mg once vs. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520585

Contacts
Contact: Ondrej Toman, MD +420532232651 ondrej.toman@atlas.cz

Sponsors and Collaborators
Masaryk University
Investigators
Principal Investigator: Ondrej Toman, MD University Hospital Brno, Department of Cardiology, Brno, Czech Republic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00520585     History of Changes
Other Study ID Numbers: CS-15-11-2006
Study First Received: August 22, 2007
Last Updated: August 22, 2007
Health Authority: Czech Republic: University Hospital Brno
Czech Republic: Masaryk University Brno

Keywords provided by Masaryk University:
atorvastatin
repolarisation
cardiomyocytes

Additional relevant MeSH terms:
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014