NCT00819442

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 9, 2009

Status Verified

January 1, 2009

Enrollment Period

2 years

First QC Date

January 8, 2009

Last Update Submit

January 8, 2009

Conditions

Dilated Cardiomyopathy

Keywords

heart failuredesminubiquitin

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    one year

Secondary Outcomes (1)

  • qualitative differences in desmin expression in cardiomyocytes of patient with heart failure

    one year

Study Arms (3)

1

PLACEBO COMPARATOR

patients without heart failure, with cardiobiopsy

Procedure: cardiobiopsy

2

EXPERIMENTAL

patients with heart failure in NYHA class I, II

Procedure: cardiobiopsy

3

EXPERIMENTAL

Patients with heart failure in NYHA class III, IV

Procedure: cardiobiopsy

Interventions

cardiobiopsyPROCEDURE

5 samples will be taken from right ventricle by Cordis bioptome

123

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • idiopatic dilated cardiomyopathy, NYHA I, II, III, IV
  • dilated left ventricle
  • ejection fraction below 45%

You may not qualify if:

  • diabetes mellitus
  • kidney failure (GFR \< 30, creatinine below 2,5 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital of Ministry of Internal Affairs and Administration

Warsaw, 02-507, Poland

Location

MeSH Terms

Conditions

Cardiomyopathy, DilatedHeart Failure

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Agnieszka Pawlak, PhD

CONTACT

+48502133158a.pawlak1@wp.pl

Robert J Gil, Professor

CONTACT

+4822 5081100kardiologia.inwazyjna@cskmswia.pl

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

January 9, 2009

Record last verified: 2009-01

Locations

PL(1)