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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00819442
Other study ID # N N402196135
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 8, 2009
Last updated January 8, 2009
Start date January 2009
Est. completion date June 2011

Study information

Verified date January 2009
Source Ministry of Scientific Research and Information Technology, Poland
Contact Agnieszka Pawlak, PhD
Phone +48502133158
Email a.pawlak1@wp.pl
Is FDA regulated No
Health authority Poland: Ministry of Science and Higher Education
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Procedure:
cardiobiopsy
5 samples will be taken from right ventricle by Cordis bioptome

Locations

Country Name City State
Poland Central Hospital of Ministry of Internal Affairs and Administration Warsaw

Sponsors (2)

Lead Sponsor Collaborator
Ministry of Scientific Research and Information Technology, Poland Polish Academy of Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary all cause mortality one year No
Secondary qualitative differences in desmin expression in cardiomyocytes of patient with heart failure one year No
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