Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients
NCT ID: NCT00299221
Last Updated: 2015-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2004-04-30
2009-12-31
Brief Summary
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Detailed Description
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The primary endpoint was the mean International Society for Heart and Lung Transplantation (ISHLT) biopsy score over the first 6 months post-transplant. Secondary endpoints included the incidence of adverse events over the first year post-transplant, as well as all-cause mortality, 12 month ISHLT biopsy score (mean), along with the incidence of proven cytomegalovirus disease. In addition, the incidence of allograft vasculopathy as assessed by angiography or intravascular ultrasound was compared between groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monotherapy
Tacrolimus alone
Tacrolimus
tacrolimus
Combination therapy
tacrolimus with mycophenolate mofetil
Tacrolimus
tacrolimus
combination therapy
MMF
Interventions
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Tacrolimus
tacrolimus
combination therapy
MMF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing a first heart transplant (no heart/kidney transplants), who receive their transplant at one of the study sites
* Specifically INCLUDED are patients on ventricular assist devices, and allosensitized recipients
Exclusion Criteria
* Inability to provide proper informed consent
* Combined organ transplantation
* Re-Transplantation
18 Years
80 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Newark Beth Israel Medical Center
OTHER
Responsible Party
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David A. Baran, MD
Director, Heart Failure and Transplant Research
Principal Investigators
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David A Baran, MD
Role: PRINCIPAL_INVESTIGATOR
Newark Beth Israel Medical Center
Locations
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Newark Beth Israel Medical Center
Newark, New Jersey, United States
Mt. Sinai Cardiovascular Institute
New York, New York, United States
Countries
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References
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Baran DA, Zucker MJ, Arroyo LH, Alwarshetty MM, Ramirez MR, Prendergast TW, Goldstein DJ, Camacho M, Gass AL, Carr C, Cohen M. Randomized trial of tacrolimus monotherapy: tacrolimus in combination, tacrolimus alone compared (the TICTAC trial). J Heart Lung Transplant. 2007 Oct;26(10):992-7. doi: 10.1016/j.healun.2007.07.022.
Baran DA, Zucker MJ, Arroyo LH, Camacho M, Goldschmidt ME, Nicholls SJ, Prevost-Fernandez J, Carr C, Adams L, Pardi S, Hou V, Binetti M, McCahill J, Chichetti J, Viloria V, Sanagustin MG, Ebuenga-Smith J, Mele L, Martin A, Blicharz D, Wolski K, Olesnicky L, Qian F, Gass AL, Cohen M. A prospective, randomized trial of single-drug versus dual-drug immunosuppression in heart transplantation: the tacrolimus in combination, tacrolimus alone compared (TICTAC) trial. Circ Heart Fail. 2011 Mar;4(2):129-37. doi: 10.1161/CIRCHEARTFAILURE.110.958520. Epub 2011 Jan 7.
Other Identifiers
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TICTAC
Identifier Type: -
Identifier Source: org_study_id
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