Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs (OPTIMA)

Description

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.

Conditions

Cardiac Failure, Graft Rejection

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Study Overview

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Study Details

Study overview

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.

Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs

Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs (OPTIMA)

Condition
Cardiac Failure
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15224

Falls Church

Inova Health System, Falls Church, Virginia, United States, 22042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≤ 18 years at enrollment
  • * Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks
  • * 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.
  • * Recipient of a multi-organ transplant
  • * History of prior solid organ transplant before the index heart transplant
  • * Ongoing mechanical circulatory support or hemodynamic instability
  • * Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression
  • * History of rejection prior to enrollment
  • * Inability to collect specified blood volume at enrollment +/- 1 week

Ages Eligible for Study

to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Inova Health Care Services,

Palak Shah, MD, PRINCIPAL_INVESTIGATOR, Inova Schar Heart and Vascular

Jason Goldberg, MD, STUDY_DIRECTOR, Inova L.J. Murphy Children's Hospital

Study Record Dates

2029-10-01