IMMUNE-DCM
Research type
Research Study
Full title
An observational study to correlate IMMUNE cell biology with Dilated CardioMyopathy patient characteristics (IMMUNE-DCM).
IRAS ID
334984
Contact name
Ioakim Spyridopoulos
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN00000000
Duration of Study in the UK
2 years, 2 months, 28 days
Research summary
Dilated cardiomyopathy, or DCM, is a disease of the heart muscle which makes the muscle walls become stretched and thin (dilated). When the thinner walls are weakened, it means the heart can’t squeeze (contract) properly to pump blood to the rest of the body. DCM affects the lower left chamber of your heart (called the left ventricle). The left ventricle usually has thick, muscular walls. With DCM, the enlarged, thinner muscle walls give the heart a rounder shape rather than its usual cone shape.
Research has shown that DCM has either a genetic and/or an environmental cause including infections which can trigger an inflammatory process. This process is called an immune-mediated inflammatory response, and research shows it is partly caused by the interaction between the amino acid Fractalkine and its receptor CX3CR1. Common infections which have been associated with starting this immune process are the cytomegalovirus (CMV), HIV and Hepatitis virus to name a few. We aim to perform an observational and feasibility study, to better understand the relationship between this immune-mediated inflammatory response with common DCM genetic mutations, CMV, HIV and hepatitis viral status, the patients’ signs, symptoms, degree of heart failure as well as the extent of inflammation and scarring on the heart. This observational study may then give us an understanding of whether specific groups of patients with dilated cardiomyopathy might benefit from a drug targeting the CX3CR1 receptor, which will help us to design future trials.We aim to recruit 100 patients with dilated cardiomyopathy and split them into 2 groups based on their degree of pump failure. We aim to do so as research has shown that the clinical course and disease process in patients with DCM differs, when split based on clinical features including, the degree of heart pump failure. This process of splitting the groups is called phenotype clustering. We will take consent and then perform tests at each initial (baseline) visit and at 6 months, as well as a heart MRI scan at baseline or within a few weeks of this baseline visit, and at 6 months. Within these visits we will also perform blood tests (on the same day as the MRI scan) other non-invasive tests such as monitoring their heart rate, rhythm, and level of activity with patch accelerometers.
REC name
Wales REC 7
REC reference
24/WA/0021
Date of REC Opinion
13 Feb 2024
REC opinion
Further Information Favourable Opinion