ATRIUM
Research type
Research Study
Full title
ATRIUM - A feasibility study to investigate lATe caRdiac toxIcity following immUnotherapy treatment for Melanoma
IRAS ID
345213
Contact name
Kate Young
Contact email
Sponsor organisation
The Royal Marsden Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
64073, CPMS
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The advent of immunotherapy has significantly improved the survival of melanoma patients in recent years. However, this success has brought about new challenges in the form of immune-related adverse events (irAEs). Of particular concern is the potential for long-term cardiac toxicity, especially as immunotherapy is now administered in both the early disease and metastatic settings, often to patients under 60 years old.
While acute cardiac toxicity during immunotherapy is rare, it can be life-threatening. The understanding of late cardiovascular toxicity is still evolving, but there is growing evidence suggesting that immunotherapy may accelerate the development of atherosclerosis and contribute to inflammation of coronary plaques, thereby increasing the risk of myocardial infarction. Addressing the risk of late cardiovascular toxicity following immunotherapy remains an unmet need.
The ATRIUM study aims to assess the feasibility of investigating late cardiac side effects associated with immunotherapy in melanoma patients undergoing long-term follow-up post-treatment. The study seeks to enroll 60 patients over a 12-month period from two recruiting centers (The Royal Marsden NHS Foundation Trust and Royal Free NHS Foundation Trust), with collaboration from a third center (Royal Brompton Hospital) for cardiac investigations.
Participants in the study will undergo screening blood tests, including cardiac biomarkers, a 12-lead ECG, and transthoracic echocardiography, as well as a cardiac MRI. They will also complete questionnaires regarding cardiac events and risk factors. Any abnormal results will be flagged, and a summary report will be provided to the patients and their general practitioners. Abnormal findings will be further investigated following standard care protocols.
Data from this feasibility study, along with subsequent research, will enable better counselling of patients regarding their cardiovascular risk prior to treatment. It will also support the development of personalized, risk-stratified surveillance programs post-treatment, aimed at optimizing cardiovascular risk factors and mitigating any potential long-term risks.
REC name
London - Central Research Ethics Committee
REC reference
25/LO/0077
Date of REC Opinion
18 Mar 2025
REC opinion
Further Information Favourable Opinion