Dilated CardiomyopathyDESMINNCT00819442
Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis
A study testing cardiobiopsy in people with Dilated Cardiomyopathy, run by Ministry of Scientific Research and Information Technology, Poland at 1 site in Poland.
Trial summary
The purpose of this study is evaluation of expression of desmin in cardiomyocytes of patients with idiopathic dilated cardiomyopathy. Analysis of relationship between desmin expression and activities of mitochondrium and expression of ubiquitin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- cardiobiopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2009to Jun 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- idiopatic dilated cardiomyopathy, NYHA I, II, III, IV
- dilated left ventricle
- ejection fraction below 45%
Who cannot join
- diabetes mellitus
- kidney failure (GFR < 30, creatinine below 2,5 mg/dl
Trial locations and contacts
1 site in 1 country.
Poland1 site
Central Hospital of Ministry of Internal Affairs and Administration
Warsaw, 02-507
About this study
Official title: Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis.
The purpose of this study is evaluation of expression of desmin in cardiomyocytes of patients with idiopathic dilated cardiomyopathy. Analysis of relationship between desmin expression and activities of mitochondrium and expression of ubiquitin.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- cardiobiopsy
- Keywords
- heart failure, desmin, ubiquitin
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiobiopsyProcedure or surgery
5 samples will be taken from right ventricle by Cordis bioptome
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | patients without heart failure, with cardiobiopsy Receives: Procedure: cardiobiopsy |
| 2 | Experimental | patients with heart failure in NYHA class I, II Receives: Procedure: cardiobiopsy |
| 3 | Experimental | Patients with heart failure in NYHA class III, IV Receives: Procedure: cardiobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: one year
Secondary outcomes (1)
qualitative differences in desmin expression in cardiomyocytes of patient with heart failure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies 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
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Scientific Research and Information Technology, Poland
- Sponsor type
- Other government
- Collaborators
- Polish Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819442
- Sponsor's protocol ID
- N N402196135
- Acronym
- DESMIN
- Status last verified
- Jan 2009
- First submitted
- 8 Jan 2009
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis.
- ClinicalTrials.gov ID
- NCT00819442
- Acronym / sponsor ID
- DESMIN / N N402196135
- Conditions
- Dilated Cardiomyopathy
- Keywords
- heart failure, desmin, ubiquitin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ministry of Scientific Research and Information Technology, PolandOther government
- Collaborators
- Polish Academy of Sciences
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 9 Jan 2009 (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 purpose of this study is evaluation of expression of desmin in cardiomyocytes of patients with idiopathic dilated cardiomyopathy. Analysis of relationship between desmin expression and activities of mitochondrium and expression of ubiquitin.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: cardiobiopsypatients without heart failure, with cardiobiopsy |
| 2 | Experimental | Procedure: cardiobiopsypatients with heart failure in NYHA class I, II |
| 3 | Experimental | Procedure: cardiobiopsyPatients with heart failure in NYHA class III, IV |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- idiopatic dilated cardiomyopathy, NYHA I, II, III, IV
- dilated left ventricle
- ejection fraction below 45%
Key exclusion criteria (2 listed)
- diabetes mellitus
- kidney failure (GFR < 30, creatinine below 2,5 mg/dl
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 |
|---|---|---|
| cardiobiopsy5 samples will be taken from right ventricle by Cordis bioptome | Procedure or surgery | 1, 2, 3 |
Primary outcome
all cause mortality
Time frame: one year
1 secondary outcome
qualitative differences in desmin expression in cardiomyocytes of patient with heart failure
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiobiopsy in people with Dilated Cardiomyopathy, run by Ministry of Scientific Research and Information Technology, Poland at 1 site in Poland.
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 3 inclusion and 2 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 9 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Agnieszka Pawlak, PhD (+48502133158, a.pawlak1@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: one year). It is what the study was designed to measure, not a finding.
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 9 Jan 2009.