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TerminatedNCT00612911Updated Feb 12, 2008

Cell Therapy in Dilated Cardiomyopathy: Observational Study

An observational study in Cardiomyopathy, Dilated, sponsored by Ministry of Health, Brazil. Terminated at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-02-12.

Sponsored by Ministry of Health, Brazil · Observational

Why this study was terminated
finish study as protocol
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
24
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

Patients with Idiopathic dilated cardiomyopathy class II to IV NYHA with ejection fraction \<35% were selected for phase I clinical trial of bone marrow mononuclear cell delivery in the coronary arteries and followed for 6 months

02

Conditions studied

  • Cardiomyopathy, Dilated
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 24 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Ministry of Health, Brazil is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with idiopathic dilated cardiomyopathy

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
24 participants (actual)

Groups and cohorts

  • Major group

    Patients with Idiopathic dilated cardiomyopathy

    Other: Cell therapy

Interventions

  • OtherCell therapy

    bone marrow mononuclear cell

06

What researchers measure

Primary outcomes

  1. echocardiography

    Time frame: 2 months

07

Study locations

1 site
  • INCL - National Institute of Cardiology Laranjeiras
    Rio de Janeiro, 22.240-006, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00612911
Lead sponsor
Ministry of Health, Brazil
First posted
Feb 12, 2008
Start date
Feb 2005
Primary completion
Aug 2006
Completion
Aug 2007
Last update
Feb 12, 2008

Study contacts

Helena F Martino
principal investigator · Brazil: National Insittute of Cardiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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