Stem Cells and Resynchronization Cardiac
RCT and SCT
Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization
1 other identifier
interventional
30
1 country
1
Brief Summary
Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 heart-failure
Started Nov 2008
Typical duration for phase_1 heart-failure
1 active site
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
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 12, 2008
CompletedFirst Posted
Study publicly available on registry
December 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 23, 2011
June 1, 2011
3.1 years
November 12, 2008
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative.
24 months
Secondary Outcomes (1)
Ejection Fraction (Echo/Sympson) and functional class(NYHA).
24 months.
Interventions
Implantation of Cardiac Ressyncrhonization combined with the implantation of Stem Cells Hematopoietics.
Pacing and Stem Cells Implantation.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Instituto de Molestias Cardiovasculareslead
- Medtroniccollaborator
Study Sites (1)
Imc - Instituto de Moléstias Cardiovasculares
São José do Rio Preto, São Paulo, 15015-210, Brazil
Related Publications (1)
Jacob JL, Salis FV, Ruiz MA, Greco OT. Labeled stem cells transplantation to the myocardium of a patient with Chagas' disease. Arq Bras Cardiol. 2007 Aug;89(2):e10-1. doi: 10.1590/s0066-782x2007001400014. English, Portuguese.
PMID: 17874006RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oswaldo Tadeu Greco, PhD
IMC - Institute of Hearth Diseases
- PRINCIPAL INVESTIGATOR
Oswaldo Tadeu Greco, PhD
IMC- Institute of Hearth Diseases
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 12, 2008
First Posted
December 2, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
June 23, 2011
Record last verified: 2011-06