Heterogeneity of Cardiomyocytes RepolarisationATORVANCT00520585
Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes
A study testing atorvastatin in people with Heterogeneity of Cardiomyocytes Repolarisation and Autonomic Changes of Cardiomyocytes Repolarisation, run by Masaryk University.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Heterogeneity of Cardiomyocytes Repolarisation, Autonomic Changes of Cardiomyocytes Repolarisation
- What is being tested?
- atorvastatin
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 2007to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- signed informed consent
- age 18 - 45 years
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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
Read the 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.
- Conditions
- Heterogeneity of Cardiomyocytes Repolarisation, Autonomic Changes of Cardiomyocytes Repolarisation
- Being tested
- atorvastatin
- Keywords
- atorvastatin, repolarisation, cardiomyocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
atorvastatin 20 mg once vs. atorvastatin 80 mg once vs. placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startAug 2007
- Study completionNov 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heterogeneity of Cardiomyocytes RepolarisationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Investigators
- Ondrej Toman, MD, Principal investigator, University Hospital Brno, Department of Cardiology, Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520585
- Sponsor's protocol ID
- CS-15-11-2006
- Acronym
- ATORVA
- Status last verified
- Aug 2007
- First submitted
- 22 Aug 2007
- Last updated
- 24 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes
- ClinicalTrials.gov ID
- NCT00520585
- Acronym / sponsor ID
- ATORVA / CS-15-11-2006
- Conditions
- Heterogeneity of Cardiomyocytes Repolarisation, Autonomic Changes of Cardiomyocytes Repolarisation
- Keywords
- atorvastatin, repolarisation, cardiomyocytes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Nov 2007 (estimated)
- First posted
- 24 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- signed informed consent
- age 18 - 45 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atorvastatinatorvastatin 20 mg once vs. atorvastatin 80 mg once vs. placebo | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ondrej Toman, MD principal investigator
University Hospital Brno, Department of Cardiology, Brno, Czech Republic
Questions about this trial
What is this clinical trial studying?
A study testing atorvastatin in people with Heterogeneity of Cardiomyocytes Repolarisation and Autonomic Changes of Cardiomyocytes Repolarisation, run by Masaryk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ondrej Toman, MD (+420532232651, ondrej.toman@atlas.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2007.