Myocarditis and Immune Checkpoint Inhibitors
Research type
Research Study
Full title
Myocarditis Complicating Treatment with Immune Checkpoint Inhibitors
IRAS ID
252295
Contact name
Michael Mahmoudi
Contact email
Sponsor organisation
Dr. Tomas G. Neilan, Massachusetts General Hospital
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Immune checkpoint inhibitors are a new class of drugs that have been approved for the treatment of a variety of cancers including lung, kidney, and liver cancer. It is anticipated that the use of these drugs will dramatically increase over the next 5-10 years. Inflammation of the heart muscle, a condition called myocarditis, has emerged as an important and potentially lethal complication of this group of drugs. Although the pivotal trials that have led to the approval of these drugs estimate the incidence of myocarditis at less than 1%, the true incidence outside the setting of clinical trials is not known.
We aim to undertake an international observational registry of patients taking these drugs as part of their cancer treatment to better understand the incidence of myocarditis associated with this group of anti-cancer drugs. The study does not involve any additional tests or procedures. Data from medical records will be collected regarding:
1. The time course of myocarditis secondary to treatment with immune checkpoint inhibitors,
2. Laboratory abnormalities that have arisen as a consequence of myocarditis, for example abnormalities in the blood test that looks for evidence of heart muscle damage,
3. Abnormalities of the heart identified on scans such ultrasound or MRI scans, and
4.The treatment that have been given for myocarditis.
This set of information will potentially enable the creation of expert recommendations for the best treatment of myocarditis arising due to treatment with immune checkpoint inhibitors.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
19/WM/0165
Date of REC Opinion
12 Jun 2019
REC opinion
Further Information Favourable Opinion