Can a new drug combo shield young hearts from transplant complications?
NCT ID NCT03386539
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This trial tests whether a combination of everolimus and low-dose tacrolimus is better than the standard tacrolimus plus mycophenolate mofetil at preventing serious long-term complications in children who have had a heart transplant. The study will follow 211 participants from 25 centers for 2.5 years, measuring the cumulative burden of major adverse events like coronary artery vasculopathy, chronic kidney disease, and acute rejection. The goal is to find a regimen that improves outcomes without increasing the risk of graft loss or other complications.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- everolimus combined with low-dose tacrolimus, compared to tacrolimus with mycophenolate mofetil
- What this could lead to
- If successful, this could identify a better immunosuppressive regimen that reduces the risk of heart transplant complications, such as coronary artery vasculopathy and kidney disease, potentially improving long-term survival and quality of life for pediatric heart transplant recipients.
- What could go wrong
- The trial is in Phase 3 but still involves a specific pediatric population, and results may not generalize to all patients. There are risks of side effects from immunosuppressants, including increased infection risk, and the study may not show a significant difference between the two treatment groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston Children's Hospital
Boston, Massachusetts, 02115, United States
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Children's Health Dallas University of Texas Southwestern
Dallas, Texas, 75235, United States
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Children's Healthcare of Atlanta Emory
Atlanta, Georgia, 30322, United States
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
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Children's Hospital at Montefiore
The Bronx, New York, 10803, United States
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Children's Hospital of New York
New York, New York, 10032, United States
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Children's Hospital of Pittsburgh of University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15224, United States
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Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
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Children's of Alabama
Birmingham, Alabama, 35233, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
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Loma Linda University
Loma Linda, California, 92354, United States
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Lurie Children's Hospital
Chicago, Illinois, 60611, United States
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Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
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Primary Children's Hospital
Salt Lake City, Utah, 84132, United States
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Seattle Children's Hospital
Seattle, Washington, 98105, United States
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Stanford University
Palo Alto, California, 94304, United States
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Texas Children's Hospital
Houston, Texas, 77027, United States
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The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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UCLA Mattel Children's Hospital
Los Angeles, California, 90095, United States
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University of Florida Congenital Heart Center
Gainesville, Florida, 32610-0297, United States
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University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
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Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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- Can a common gout pill shield hearts in kidney disease?
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