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Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
Up to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Blood samples will be collected for miR evaluation at: 1. specified time intervals after transplant and 2. when a clinical event of interest occurs, including treated rejection, or infection."
  • "Additional data collection will include demographics, medical history, medications, human leukocyte (HLA)/donor specific antibody (DSA) evaluations, endomyocardial biopsy (EMB), echocardiography, donor-derived cell-free DNA (dd-cfDNA), and other post-transplant events and testing."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at microRNAs, tiny molecules in blood that help control how genes work, in children and teens after a heart transplant. It aims to learn whether these molecules, linked to medicine doses and levels, can show how the immune system is working and predict infection or rejection, when the body attacks the new heart.

This study aims to discover circulating microRNAs (associated with drug doses and levels) that can be used to characterize the overall immune state in pediatric heart transplant patients and predict patients that will go on to develop infection and rejection. MicroRNAs (miRs) are small, non-coding RNA molecules that regulate gene expression and serve as molecular biomarkers found in the circulation.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Was age 18 or younger when placed on the heart transplant waiting list.
  • Had a heart transplant 10 to 50 days before joining the study.
  • Plans to have follow-up care at the transplant center for at least one year.
  • Has a caregiver who can and will follow the study visit schedule, procedures, and requirements.

Who can't join

  • Received more than one organ in the transplant.
  • Had another solid organ transplant before this heart transplant.
  • Still needs a machine to help pump blood, or has unstable blood flow after the transplant.
  • Has an active infection that needs a hospital stay or drugs to treat it. Drugs given after transplant to prevent or keep infections under control do not count.
  • Was treated for rejection of the new heart before joining the study.
  • Cannot have the required amount of blood drawn after joining and before 50 days after the transplant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age ≤ 18 years at time of transplant listing * Subject is within 10-50 days post-orthotopic heart transplant at time of enrollment. * Planned follow-up at the transplant center for a minimum of one-year. * Caregiver able and willing to comply with the study visit schedule, study procedures, and study requirements. Exclusion Criteria: * Recipient of a multi-organ transplant * History of prior solid organ transplant before the index heart transplant * Ongoing mechanical circulatory support or hemodynamic instability after transplant * Active infection requiring either a) hospitalization or b) treatment with antimicrobial drugs (does not include prophylaxis for infection or suppressive antibiotics given after transplant) * History of treated rejection prior to study enrollment * Inability to collect specified blood volume after enrollment and prior to 50 days post-transplant

Study sites (7)

CO

IL

MI

NY

PA

TN

TX