NCT00349271

Brief Summary

The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
182

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

4.9 years

First QC Date

July 5, 2006

Last Update Submit

March 9, 2017

Conditions

Chagas Cardiomyopathy

Keywords

Chagas CardiomyopathyDilated Cardiomyopathystem cellsTherapeuticsRandomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

  • increase of the ejection fraction of the left ventricle

    1 year

Secondary Outcomes (4)

  • Death by any cause within 1 year of intervention

    1 year

  • Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline

    1 year

  • Difference in NYHA functional class at six months and baseline

    six months

  • Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months

    1 year

Study Arms (2)

Stem Cell therapy

EXPERIMENTAL

Stem Cell therapy

Procedure: Stem cellDrug: Filgrastime (G-CSF)

Standart therapy

ACTIVE COMPARATOR

Standart therapy

Drug: Standart therapy

Interventions

Stem cellPROCEDURE

Stem cell

Stem Cell therapy
Filgrastime (G-CSF)DRUG

Filgrastime (G-CSF)

Stem Cell therapy
Standart therapyDRUG

All drug with clinical evidence of benefical effect in Chagas disease

Standart therapy

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of dilated cardiomyopathy according to WHO criteria
  • Syndromic heart failure in functional class III or IV of the NYHA
  • Enrollment and continuous follow-up in cardiac out-patient clinic
  • Adequate medical therapy after optimization therapy
  • Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule

You may not qualify if:

  • Valvular diseases, except functional mitral or tricuspid reflow
  • Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries
  • Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism
  • Sustained ventricular tachycardia
  • Abusive use of alcohol or illicit drugs
  • Pregnancy
  • Use of cardio toxic drugs
  • Any co-morbidity with impact in life expectancy in 2 years
  • Renal function compromised (creatinine above 2 mg/dl)
  • Definitive implant of pace-makers, resynchronizers and CDIs
  • Heart failure with symptoms initiating less than 1 year ago
  • Active systemic arterial hypertension or history of hypertension

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

Related Publications (1)

  • Ribeiro Dos Santos R, Rassi S, Feitosa G, Grecco OT, Rassi A Jr, da Cunha AB, de Carvalho VB, Guarita-Souza LC, de Oliveira W Jr, Tura BR, Soares MB, Campos de Carvalho AC; Chagas Arm of the MiHeart Study Investigators. Cell therapy in Chagas cardiomyopathy (Chagas arm of the multicenter randomized trial of cell therapy in cardiopathies study): a multicenter randomized trial. Circulation. 2012 May 22;125(20):2454-61. doi: 10.1161/CIRCULATIONAHA.111.067785. Epub 2012 Apr 20.

    PMID: 22523306DERIVED

MeSH Terms

Conditions

Chagas CardiomyopathyCardiomyopathy, Dilated

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Chagas DiseaseTrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne DiseasesCardiomyopathiesHeart DiseasesCardiovascular DiseasesCardiomegalyLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Ricardo R Santos, MD,PhD

    Centro de pesquisa Gonzalo Muniz

    PRINCIPAL INVESTIGATOR

  • Gilson Feitosa, MD

    Hospital Santa Isabel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 6, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

March 13, 2017

Record last verified: 2017-03

Locations

BR(1)