Heart failure & cardiomyopathies
The teammate trial: Study design and rationale tacrolimus and everolimus against tacrolimus and mycophenolate mofetil (MMF) in pediatric heart transplantation using the major adverse transplant event (MATE) score
Study context
- Population
- Children aged <21 years at heart transplantation (HT), randomised at 6 months post-HT; excluded recurrent rejection, multi-organ recipients, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2target sample size 210
- Planned comparison
- Everolimus (EVL)/low-dose TAC (LD-TAC) vs tacrolimus (TAC)/MMF
- Primary endpoint
- MATE score:
- Ordinal surrogate of frequency and severity of MATEs
- Validated against graft loss
Methodological detailsmulticentre, 1:1 randomisation, 25 sites, Follow-up 30 months, Enrollment complete; follow-up to be completed in 2023
- Multicentre
- 1:1 randomisation
- 25 sites
- Follow-up 30 months
- Enrollment complete; follow-up to be completed in 2023
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
The teammate trial: Study design and rationale tacrolimus and everolimus against tacrolimus and MMF in pediatric heart transplantation using the major adverse transplant event (MATE) score. Am Heart J. Published 23 February 2023. doi:10.
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