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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)

Primary Purpose

Dilated Cardiomyopathy

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
cardiobiopsy
Sponsored by
Ministry of Scientific Research and Information Technology, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dilated Cardiomyopathy focused on measuring heart failure, desmin, ubiquitin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 8, 2009
Last Updated
January 8, 2009
Sponsor
Ministry of Scientific Research and Information Technology, Poland
Collaborators
Polish Academy of Sciences
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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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