NCT00612911

Brief Summary

Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 12, 2008

Completed
Last Updated

February 12, 2008

Status Verified

January 1, 2008

Enrollment Period

1.5 years

First QC Date

January 23, 2008

Last Update Submit

January 29, 2008

Conditions

Cardiomyopathy, Dilated

Outcome Measures

Primary Outcomes (1)

  • echocardiography

    2 months

Study Arms (1)

Major group

Patients with Idiopathic dilated cardiomyopathy

Other: Cell therapy

Interventions

Cell therapyOTHER

bone marrow mononuclear cell

Major group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with idiopathic dilated cardiomyopathy

You may qualify if:

  • Diagnosis of idiopathic dilated cardiomyopathy
  • Optimized therapy and for idiopathic dilated cardiomyopathy
  • Left ventricular ejection fraction (Simpson) \< 35%
  • Peak oxygen consumption (VO2 peak) \< 16 mL.kg-1min-1
  • Functional classes II-IV of the NYHA

You may not qualify if:

  • dilated cardiopathies of ischemic or chagasic origin
  • primary valve disease
  • excessive use of alcohol or illicit drugs
  • pregnancy
  • ventricular arrhythmias
  • any co-morbidity with impact on survival

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INCL - National Institute of Cardiology Laranjeiras

Rio de Janeiro, Rio de Janeiro, 22.240-006, Brazil

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Helena F Martino

    Brazil: National Insittute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 12, 2008

Study Start

February 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2007

Last Updated

February 12, 2008

Record last verified: 2008-01

Locations

BR(1)