New clinical trial hopes to improve long-term outcomes for heart transplant patients

 If your child or teenager has had a heart transplant in the last six months, they may be eligible to participate in a clinical trial developed to test a new anti-rejection therapy. In the process, they can play an important part in building a base of evidence that will help advance care for future generations.

The TEAMMATE (Tacrolimus/Everolimus vs. Tacrolimus/MMF in pediatric heart transplant recipients using the MATE Score) trial is the first multicenter randomized trial designed to address key scientific questions in the field of pediatric heart transplantation. 

The trial, which is a partnership between Boston Children’s Hospital and Stanford Children’s Hospital, is currently enrolling children and is about 75 percent full. However, there is a strong need for more transplant recipients, and in particular teens, to participate, according to Kevin P. Daly, MD, an attending with Boston Children’s Department of Cardiology who is helping to lead the TEAMMATE effort.

The need for more data

He explains that only 400 to 500 pediatric heart transplants are performed in the U.S. each year. With such low numbers, conducting research to better understand this medically complex population has been challenging. As a result, most anti-rejection medications on the market today have been approved for adults and are given off label to children.

Yet, children’s bodies are still developing and they don’t handle medications in the same way, making it essential to find a way to study children who have had a heart transplant and determine the best options for their specific needs. That’s where the TEAMMATE trial hopes to fill in the gaps.

Exploring two immunosuppressant protocols

“We want to look at two drug protocols [everolimus/low-dose tacrolimus, a new approach] and tacrolimus/mycophenolate mofetil [the approach currently used] over a 30-month period in the context of six key outcomes to better understand this population and define the best anti-rejection medication protocol to use,” Daly says. 

“We want to determine whether the new anti-rejection medication combination can reduce or prevent some of the common complications of transplant that limit survival, including rejection, coronary artery disease, and kidney disease, compared to the current standard of care,” he says.

“Our study will provide data that shows the effectiveness of the both medication combinations, as well as the trade-offs,” he adds.

Recruiting teens

Patient screening and recruitment for the study began in February 2018 and will be completed by spring 2020. The goal is to enroll a total of 210 children who are six months post-transplant at 26 heart transplant centers across the U.S.

Right now, the study is actively recruiting all transplant patients with a focus on including more teens, since they have been slow to sign up, yet are an important part of the equation. Daly points out that many teens may be hesitant to participate because they are used to their current medications and don’t want to make any changes.

But he stresses that the two protocols used in the study have both been determined to be effective in preventing rejection. Further, participating in this effort will go a long way toward building a knowledge base that can benefit participants as they get older, as well as helping to improve outcomes for future generations.

Building an evidence base 

“Our goal is to build evidence-based care for pediatric heart transplant recipients and understand how patients do over their life cycle so we can try to extend the timeframe their transplant will last,” Daly says. 

The study also marks the first time the pediatric heart transplant community has collaborated on a project to advance understanding and care for future generations. The hope is that this will now encourage other similar efforts, ultimately providing data that will improve the care of pediatric heart transplant recipients.

Learn more about the TEAMMATE trial.