NCT00520585

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

August 24, 2007

Status Verified

August 1, 2007

First QC Date

August 22, 2007

Last Update Submit

August 22, 2007

Conditions

Heterogeneity of Cardiomyocytes RepolarisationAutonomic Changes of Cardiomyocytes Repolarisation

Keywords

atorvastatinrepolarisationcardiomyocytes

Interventions

atorvastatinDRUG

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

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • signed informed consent
  • age 18 - 45 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Ondrej Toman, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ondrej Toman, MD

CONTACT

+420532232651ondrej.toman@atlas.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 24, 2007

Study Start

August 1, 2007

Study Completion

November 1, 2007

Last Updated

August 24, 2007

Record last verified: 2007-08