CMR in Heart Transplant – Diagnostic Accuracy Study
Research type
Research Study
Full title
A prospective blinded pilot study evaluating the sensitivity and specificity of Cardiac Magnetic Resonance Imaging (a non-invasive imaging tool) for the diagnosis of rejection in heart transplant recipients.
IRAS ID
367583
Contact name
Nahal Raza
Contact email
Sponsor organisation
Royal Brompton & Harefield Hospitals, Part of Guy’s and St Thomas’ NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Heart transplant rejection remains a significant clinical problem and is currently diagnosed using heart biopsies. A biopsy involves taking small samples from the heart using a catheter. While effective, it is an invasive procedure with a small risk of complications and can be uncomfortable for patients. It also only assesses a small part of the heart.
Cardiac magnetic resonance (CMR) is a non-invasive scan that provides detailed images of the whole heart. Early research suggests that CMR may be able to detect changes in the heart muscle associated with rejection, but this has not yet been confirmed in a well-designed study.
This study aims to assess whether CMR can be used to detect rejection after heart transplant. We will recruit 20 adult heart transplant patients, including those with and without biopsy-proven rejection. All participants will undergo a CMR scan in addition to their routine clinical care. The scans will be analysed by specialists who are blinded to the biopsy results to ensure an unbiased comparison.
The study is designed as a pilot to assess feasibility, including whether patients are willing to undergo the scan and whether the imaging can be performed within a suitable timeframe after biopsy. It will also provide data to support the design of a larger future study.
Participants are unlikely to benefit directly from taking part. However, if CMR is shown to be effective, it could reduce the need for invasive biopsies in the future and improve patient experience and outcomes.
The study has been discussed with a patient and public involvement group, who strongly supported the research and the use of non-invasive imaging.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
26/EM/0149
Date of REC Opinion
9 Jul 2026
REC opinion
Further Information Favourable Opinion