# PCSK9 Inhibition after Heart Transplantation

> **NIH NIH R33** · STANFORD UNIVERSITY · 2020 · $461,936

## Abstract

Project Summary/Abstract:
 Cardiac transplantation is the ultimate treatment option for patients with end stage heart failure.
Cardiac allograft vasculopathy remains a leading cause of morbidity and mortality after transplantation.
Dyslipidemia is a major contributor to cardiac allograft vasculopathy and is suboptimally controlled with current
medications. The PCSK9 inhibitors are novel lipid lowering agents which have been shown to significantly
lower cholesterol levels and lead to coronary plaque regression in non-transplant individuals. This class of
medication has not been tested in cardiac transplant recipients. The objective of this project is to investigate
the safety and efficacy of the PCSK9 inhibitor, alirocumab in preventing the development of cardiac allograft
vasculopathy. During the first month after cardiac transplantation subjects will undergo coronary angiography
with intravascular ultrasound measurements of plaque, vessel and lumen volumes in the left anterior
descending coronary artery. Using a coronary pressure wire, epicardial artery and microvascular physiology
will be assessed. Finally, endothelial function will be assayed. Subjects will then be randomized in a double
blind fashion to either alirocumab or placebo. Baseline and serial lipid values and inflammatory markers will be
measured. After 1 year, the above assessment will be repeated. The primary endpoint is the change in
plaque volume based on intravascular ultrasound assessment. Secondary endpoints will be the effect of
alirocumab on coronary physiology, endothelial function and inflammatory markers. An important secondary
aim of this project is to investigate the role of coronary physiology and endothelial function assessment for
predicting cardiac allograft vasculopathy, independent of intravascular ultrasound findings. We believe this
project will contribute significantly to the evidence base for an important health matter, namely the optimal
medical treatment of cardiac transplant recipients.

## Key facts

- **NIH application ID:** 9899367
- **Project number:** 4R33HL139929-02
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** WILLIAM F FEARON
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $461,936
- **Award type:** 4N
- **Project period:** 2019-02-15 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9899367

## Citation

> US National Institutes of Health, RePORTER application 9899367, PCSK9 Inhibition after Heart Transplantation (4R33HL139929-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9899367. Licensed CC0.

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