Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis - Full Text View

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

This study is not yet open for participant recruitment.

Verified by Ministry of Scientific Research and Information Technology, Poland, January 2009

First Received: January 8, 2009 No Changes Posted

Sponsors and Collaborators:	Ministry of Scientific Research and Information Technology, Poland Polish Academy of Sciences
Information provided by:	Ministry of Scientific Research and Information Technology, Poland
ClinicalTrials.gov Identifier:	NCT00819442

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

MedlinePlus related topics: Cardiomyopathy Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Parallel Assignment
Official Title:	Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis.

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
1: Placebo Comparator patients without heart failure, with cardiobiopsy	Procedure: cardiobiopsy 5 samples will be taken from right ventricle by Cordis bioptome
2: Experimental patients with heart failure in NYHA class I, II	Procedure: cardiobiopsy 5 samples will be taken from right ventricle by Cordis bioptome
3: Experimental 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

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

Keywords provided by Ministry of Scientific Research and Information Technology, Poland:

heart failure
desmin
ubiquitin

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Dilated Cardiomyopathy
Cardiomyopathy, Dilated

Congenital Abnormalities
Cardiomegaly
Cardiomyopathies

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiomyopathy, Dilated

Cardiovascular Diseases
Cardiomegaly
Cardiomyopathies

ClinicalTrials.gov processed this record on May 06, 2009