Graft Rejection / Cardiac Failure · Observational Study

Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is an active prospective observational study investigating circulating microRNAs as biomarkers to predict infection and rejection in pediatric heart transplant recipients over 2 years of follow-up. No results have been reported in this registry record; the study is currently recruiting and hypothesis-generating in nature.

What was studied

Observational. Cardiac Failure, Graft Rejection; to 18 Years. Intervention: Observational measurement of circulating microRNAs; no therapeutic intervention. n = 150. 6 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This study is at an early hypothesis-generation stage and cannot guide clinical practice. Results, once available, may identify microRNA signatures useful for immunosuppression optimization and infection/rejection surveillance in children, but validation in independent cohorts will be necessary.

Plain-language summary

This is an active observational registry study with no reported results, enrolling 150 pediatric heart transplant recipients to discover circulating microRNA biomarkers predicting infection and rejection.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients (assessed at up to 2 years post-transplant); Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients (assessed at up to 2 years post-transplant)

DesignObservational

PopulationCardiac Failure, Graft Rejection; to 18 Years

Sample size150

InterventionObservational measurement of circulating microRNAs; no therapeutic intervention

Setting6 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment150

Primary outcome 1Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients, up to 2 years post-transplant

Primary outcome 2Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients, up to 2 years post-transplant

Follow-up durationup to 2 years post-transplant

Clinical bottom line

Caveats

This is a registry record with no results posted; no efficacy, predictive accuracy, or clinical outcomes are reported.
Single-centre observational design limits generalizability and cannot establish causal or predictive inference without external validation.
No information on microRNA measurement methods, statistical analysis plan, or data quality assurance.
No sample size justification or power calculation provided for the planned 150 participants.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective observational cohort study with defined outcomes and follow-up protocol.

Directness

strong

Directly measures circulating microRNAs in pediatric heart transplant recipients post-transplant.

Consistency

insufficient

Single-centre study; no comparative data or prior validation reported.

Risk of bias

insufficient

Registry record does not describe blinding, adjudication, or potential confounders.

Sample adequacy

moderate

Estimated 150 participants planned; adequate for exploratory biomarker discovery.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06532890). This is a study registration, not published results. Lead sponsor: Northwestern University. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: Cardiac Failure, Graft Rejection. Primary outcome measures: Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients , up to 2 years post-transplant; Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients , up to 2 years post-transplant. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT06532890Graft RejectionCardiac FailureNorthwestern University