RECRUITING

Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs (OPTIMA)

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Conditions

Cardiac FailureGraft Rejection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs

Quick Facts

Study Start:2025-02-06
Study Completion:2029-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06532890

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.

Ages Eligible for Study:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≤ 18 years at enrollment
  2. * Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks
  3. * Planned follow-up at the transplant center for a minimum of one-year.
  4. * Caregiver able and willing to comply with the study visit schedule, study procedures, and study requirements.
  1. * Recipient of a multi-organ transplant
  2. * History of prior solid organ transplant before the index heart transplant
  3. * Ongoing mechanical circulatory support or hemodynamic instability
  4. * Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression
  5. * History of rejection prior to enrollment
  6. * Inability to collect specified blood volume at enrollment +/- 1 week

Contacts and Locations

Study Contact

Palak Shah, MD
CONTACT
(703) 776-8000
palak.shah@inova.org
Michaela Ramandanes, MPH
CONTACT
(703) 776-6466
michaela.ramandanes@inova.org

Principal Investigator

Palak Shah, MD
PRINCIPAL_INVESTIGATOR
Inova Schar Heart and Vascular
Jason Goldberg, MD
STUDY_DIRECTOR
Inova L.J. Murphy Children's Hospital

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Inova Health System
Falls Church, Virginia, 22042
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-06
Study Completion Date2029-10-01

Study Record Updates

Study Start Date2025-02-06
Study Completion Date2029-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiac Failure
  • Graft Rejection