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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

Tracking Information
First Submitted Date  ICMJE January 8, 2009
First Posted Date  ICMJE January 9, 2009
Last Update Posted Date January 9, 2009
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
all cause mortality [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
qualitative differences in desmin expression in cardiomyocytes of patient with heart failure [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis
Official Title  ICMJE Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Dilated Cardiomyopathy
Intervention  ICMJE Procedure: cardiobiopsy
5 samples will be taken from right ventricle by Cordis bioptome
Study Arms  ICMJE
  • Placebo Comparator: 1
    patients without heart failure, with cardiobiopsy
    Intervention: Procedure: cardiobiopsy
  • Experimental: 2
    patients with heart failure in NYHA class I, II
    Intervention: Procedure: cardiobiopsy
  • Experimental: 3
    Patients with heart failure in NYHA class III, IV
    Intervention: Procedure: cardiobiopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 8, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00819442
Other Study ID Numbers  ICMJE N N402196135
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Robert J. Gil, Polish Academy of Sciences
Study Sponsor  ICMJE Ministry of Scientific Research and Information Technology, Poland
Collaborators  ICMJE Polish Academy of Sciences
Investigators  ICMJE Not Provided
PRS Account Ministry of Scientific Research and Information Technology, Poland
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP