NCT00333827

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

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
completed

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
5 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

6.9 years

First QC Date

June 5, 2006

Last Update Submit

March 9, 2017

Conditions

Dilated Cardiomyopathy

Keywords

Dilated Cardiomyopathystem cellsTherapeuticsRandomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

  • increase of the ejection fraction of the left ventricle

    6 months

Secondary Outcomes (5)

  • Death by any cause

    1 year

  • Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline

    1 year

  • Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire

    6 month

  • Difference in NYHA functional class

    6 month

  • Percent number of patients that reached an absolute increase of 5% in ejection fraction

    1 year

Study Arms (2)

Optimal Therapy

ACTIVE COMPARATOR

Optimal therapy for cardiac failure

Drug: optimal therapy for cardiaca failure

cell therapy

EXPERIMENTAL

stem cell

Procedure: cell

Interventions

optimal therapy for cardiaca failureDRUG

optimal therapy for cardiaca failure

Optimal Therapy
cellPROCEDURE

stem cell

cell 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)

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)

  • Martino H, Brofman P, Greco O, Bueno R, Bodanese L, Clausell N, Maldonado JA, Mill J, Braile D, Moraes J Jr, Silva S, Bozza A, Santos B, Campos de Carvalho A; Dilated Cardiomyopathy Arm of the MiHeart Study Investigators. Multicentre, randomized, double-blind trial of intracoronary autologous mononuclear bone marrow cell injection in non-ischaemic dilated cardiomyopathy (the dilated cardiomyopathy arm of the MiHeart study). Eur Heart J. 2015 Nov 7;36(42):2898-904. doi: 10.1093/eurheartj/ehv477. Epub 2015 Sep 20.

    PMID: 26392433RESULT

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Carboxylesterase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and Coenzymes

Study Officials

  • Antonio Carlos C de Carvalho, MD,PhD

    INCL

    STUDY DIRECTOR

  • Bernardo R Tura, Md,MsC

    INCL

    STUDY CHAIR

  • Augusto Z Bozza, MD

    INCL

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 5, 2006

First Posted

June 6, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

March 13, 2017

Record last verified: 2017-03

Locations

BR(1)