Graft Rejection / Cardiac Failure · Observational Study

OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

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 a recruiting observational study designed to develop a circulating microRNA biomarker panel to predict infection and rejection in adult heart transplant recipients. No efficacy, safety, or validation results are available; this registry entry describes the study design and aims only.

What was studied

Observational. Cardiac Failure, Graft Rejection; age from 18 Years; to 99 Years. Intervention: Circulating microRNA biomarker panel assessment (observational; no intervention assigned).. n = 250. 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 in early development and should not yet inform clinical practice. Results, when available, will need independent validation before clinical application of any biomarker panel.

Plain-language summary

This is a recruiting observational study designed to develop and validate a biomarker panel; no results are reported in this registry record.

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 3 years post - transplant); Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients (assessed at up to 3 years post - transplant)

DesignObservational

PopulationCardiac Failure, Graft Rejection; age from 18 Years; to 99 Years

Sample size250

InterventionCirculating microRNA biomarker panel assessment (observational; no intervention assigned).

Setting6 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment250

Primary outcome: Time-to-Event Analysis of Circulating microRNAs Predicting Infectionup to 3 years post-transplant

Primary outcome: Time-to-Event Analysis of Circulating microRNAs Predicting Rejectionup to 3 years post-transplant

Clinical bottom line

This study is in early development and should not yet inform clinical practice. Results, when available, will need independent validation before clinical application of any biomarker panel.

Caveats

No results are reported in this registry record; study is still recruiting.
Observational design without a control or comparator group.
Inconsistency between study title ('Adult') and stated primary outcomes ('Pediatric')—target population unclear.
Biomarker validation and clinical utility have not been assessed.

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

limited

Observational design without control group or randomization limits causal inference.

Directness

moderate

Biomarker panel development aims to predict clinically important outcomes (infection, rejection).

Consistency

insufficient

No results reported; cannot assess consistency with prior evidence.

Risk of bias

insufficient

Study still recruiting; methods for mitigating bias not detailed in registry record.

Sample adequacy

moderate

Planned enrollment of 250 participants is reasonable for biomarker discovery but underpowered for rare events.

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 (NCT06939751). This is a study registration, not published results. Lead sponsor: Northwestern University. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 250 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 3 years post - transplant; Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients , up to 3 years post - transplant. Brief summary: This study aims to develop and refine a microRNA (miR) biomarker panel that can be used to phenotype net immune state after heart transplantation using circulating miRs (associated with drug doses and levels). These miRs will be used to characterize the overall immune state in adult 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.

Graft RejectionNCT06939751Cardiac FailureNorthwestern University