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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Ministry of Scientific Research and Information Technology, Poland.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Polish Academy of Sciences
Information provided by:
Ministry of Scientific Research and Information Technology, Poland
ClinicalTrials.gov Identifier:
NCT00819442
First received: January 8, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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 Intervention
Dilated Cardiomyopathy
Procedure: cardiobiopsy

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Ministry of Scientific Research and Information Technology, Poland:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • qualitative differences in desmin expression in cardiomyocytes of patient with heart failure [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Prof. Robert J. Gil, Polish Academy of Sciences
ClinicalTrials.gov Identifier: NCT00819442     History of Changes
Other Study ID Numbers: N N402196135
Study First Received: January 8, 2009
Last Updated: January 8, 2009
Health Authority: Poland: Ministry of Science and Higher Education

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

ClinicalTrials.gov processed this record on October 19, 2014