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

January 8, 2009 updated by: Ministry of Scientific Research and Information Technology, Poland

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-507
        • Central Hospital of Ministry of Internal Affairs and Administration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
qualitative differences in desmin expression in cardiomyocytes of patient with heart failure
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Scientific Research and Information Technology, Poland

Collaborators

Polish Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ANTICIPATED)

January 1, 2011

Study Completion (ANTICIPATED)

June 1, 2011

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (ESTIMATE)

January 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2009

Last Update Submitted That Met QC Criteria

January 8, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N N402196135

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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