# MicroRNA Biomarkers of Allograft Rejection and Cardiac Allograft Vasculopathy in Cardiac Transplantation

> **NIH NIH K23** · INOVA HEALTH CARE SERVICES · 2020 · $185,760

## Abstract

Project Summary
 This purpose of this research proposal is to support the development of Palak Shah, MD, MS into an
independent investigator, and to conduct novel, transformative explorations of circulating, cell-free microRNAs
(ccf-miR) in heart transplantation. Circulating, cell-free miRs may serve as non-invasive biomarkers of allograft
rejection and cardiac allograft vasculopathy (CAV), two leading causes of morbidity and mortality in heart
transplant recipients. The candidate, Dr. Shah, has demonstrated his long-standing commitment to academic
medicine by pursuing a Masters in Clinical and Translational Research. As a junior faculty member, Dr. Shah’s
early work has focused on the identification of blood-based biomarkers to better manage patients with
advanced heart failure, left ventricular assist devices (LVADs), and following transplantation. The K23 award
will extend initial experiences in genomic assay development and biomarker validation to include: 1) isolation
of ccf-miRs from blood samples and preparation of biospecimens for next-generation sequencing; 2) sequence
data alignment and bioinformatic interpretation of sequence data; and 3) the development of a clinical panel of
ccf-miR biomarkers to detect allograft rejection using biostatistical analyses that combine transcriptomic and
clinical data.
 To accomplish these goals, a comprehensive career development plan has been formulated that includes
both formal coursework and mentored research under the close supervision and guidance of a senior team of
experienced mentors. The mentorship team includes multiple thought-leaders with detailed expertise relevant
to the career goals of the applicant: Christopher O’Connor, MD (clinical validation of heart failure biomarkers
and trial design), Jun Zhu, PhD (RNA-sequencing and bioinformatic analyses), Hannah Valantine, MD (cardiac
transplantation and genomic biomarkers), and Christopher deFilippi, MD (cardiovascular biomarker discovery
and validation). The specific aims of the research are to 1) Determine the ccf-miR transcriptome of cardiac
transplant recipients to identify novel miR biomarkers that distinguish cardiac allograft rejection; 2) Distinguish
ccf-miR biomarkers of chronic rejection manifest as cardiac allograft vasculopathy.
 Previous groundwork and training have prepared Dr. Shah to successfully undertake the proposed
research, and to transition him into an independent investigator. The study results are expected to establish a
framework for using ccf-miRs as diagnostic biomarkers of allograft rejection and CAV. Once clinically validated
in a future multicenter study, ccf-miRs can be used to non-invasively diagnose allograft rejection and CAV in
heart transplant patients.

## Key facts

- **NIH application ID:** 9891497
- **Project number:** 1K23HL143179-01A1
- **Recipient organization:** INOVA HEALTH CARE SERVICES
- **Principal Investigator:** Palak Shah
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $185,760
- **Award type:** 1
- **Project period:** 2020-07-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9891497

## Citation

> US National Institutes of Health, RePORTER application 9891497, MicroRNA Biomarkers of Allograft Rejection and Cardiac Allograft Vasculopathy in Cardiac Transplantation (1K23HL143179-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9891497. Licensed CC0.

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