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Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis (DESMIN)

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ClinicalTrials.gov Identifier: NCT00819442
Recruitment Status : Unknown
Verified January 2009 by Ministry of Scientific Research and Information Technology, Poland.
Recruitment status was:  Not yet recruiting
First Posted : January 9, 2009
Last Update Posted : January 9, 2009
Sponsor:
Collaborator:
Polish Academy of Sciences
Information provided by:
Ministry of Scientific Research and Information Technology, Poland

Brief 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.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Procedure: cardiobiopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis.
Study Start Date : January 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : June 2011


Arm Intervention/treatment
Placebo Comparator: 1
patients without heart failure, with cardiobiopsy
Procedure: cardiobiopsy
5 samples will be taken from right ventricle by Cordis bioptome

Experimental: 2
patients with heart failure in NYHA class I, II
Procedure: cardiobiopsy
5 samples will be taken from right ventricle by Cordis bioptome

Experimental: 3
Patients with heart failure in NYHA class III, IV
Procedure: cardiobiopsy
5 samples will be taken from right ventricle by Cordis bioptome




Primary Outcome Measures :
  1. all cause mortality [ Time Frame: one year ]

Secondary Outcome Measures :
  1. qualitative differences in desmin expression in cardiomyocytes of patient with heart failure [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • idiopatic dilated cardiomyopathy, NYHA I, II, III, IV
  • dilated left ventricle
  • ejection fraction below 45%

Exclusion Criteria:

  • diabetes mellitus
  • kidney failure (GFR < 30, creatinine below 2,5 mg/dl

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819442


Contacts
Contact: Agnieszka Pawlak, PhD +48502133158 a.pawlak1@wp.pl
Contact: Robert J Gil, Professor +4822 5081100 kardiologia.inwazyjna@cskmswia.pl

Locations
Poland
Central Hospital of Ministry of Internal Affairs and Administration Active, not recruiting
Warsaw, Poland, 02-507
Sponsors and Collaborators
Ministry of Scientific Research and Information Technology, Poland
Polish Academy of Sciences

Responsible Party: Prof. Robert J. Gil, Polish Academy of Sciences
ClinicalTrials.gov Identifier: NCT00819442     History of Changes
Other Study ID Numbers: N N402196135
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: January 9, 2009
Last Verified: January 2009

Keywords provided by Ministry of Scientific Research and Information Technology, Poland:
heart failure
desmin
ubiquitin

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly