Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis (DESMIN)
Primary Purpose
Dilated Cardiomyopathy
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
cardiobiopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Dilated Cardiomyopathy focused on measuring heart failure, desmin, ubiquitin
Eligibility 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
Sites / Locations
- Central Hospital of Ministry of Internal Affairs and Administration
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
patients without heart failure, with cardiobiopsy
patients with heart failure in NYHA class I, II
Patients with heart failure in NYHA class III, IV
Outcomes
Primary Outcome Measures
all cause mortality
Secondary Outcome Measures
qualitative differences in desmin expression in cardiomyocytes of patient with heart failure
Full Information
NCT ID
NCT00819442
First Posted
January 8, 2009
Last Updated
January 8, 2009
Sponsor
Ministry of Scientific Research and Information Technology, Poland
Collaborators
Polish Academy of Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00819442
Brief Title
Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis
Acronym
DESMIN
Official Title
Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ministry of Scientific Research and Information Technology, Poland
Collaborators
Polish Academy of Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy
Keywords
heart failure, desmin, ubiquitin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
patients without heart failure, with cardiobiopsy
Arm Title
2
Arm Type
Experimental
Arm Description
patients with heart failure in NYHA class I, II
Arm Title
3
Arm Type
Experimental
Arm Description
Patients with heart failure in NYHA class III, IV
Intervention Type
Procedure
Intervention Name(s)
cardiobiopsy
Intervention Description
5 samples will be taken from right ventricle by Cordis bioptome
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
one year
Secondary Outcome Measure Information:
Title
qualitative differences in desmin expression in cardiomyocytes of patient with heart failure
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnieszka Pawlak, PhD
Phone
+48502133158
Email
a.pawlak1@wp.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Robert J Gil, Professor
Phone
+4822 5081100
Email
kardiologia.inwazyjna@cskmswia.pl
Facility Information:
Facility Name
Central Hospital of Ministry of Internal Affairs and Administration
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
12. IPD Sharing Statement
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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
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