Using Cardiovascular Magnetic Resonance Identified Scar as the Benchmark Risk Indication Tool for Implantable Cardioverter Defibrillators in Patients With Non-Ischemic Cardiomyopathy and Severe Systolic Heart Failure

What this Trial Is About

Researchers are evaluating the use of Implantable Cardioverter-Defibrillators ICDs in patients diagnosed with heart failure due to Non-Ischemic Cardiomyopathy NICM, a condition where the heart is weakened but not from blocked arteries. The trial aims to compare the overall survival rates of patients who receive an ICD versus those who do not over a period of 36 months and up to 10 years. This research addresses conflicting evidence about the benefits of ICDs and seeks to improve treatment guidelines for this patient group. Participants will be randomly assigned to one of two groups one group will receive an ICD or a Cardiac Resynchronisation Therapy Defibrillator CRTD, which are devices implanted under the skin to detect and treat dangerous heart rhythms, and the other group will not receive an ICD but may have an Implantable Loop Recorder or a Cardiac Resynchronisation Therapy Pacemaker CRTP. Both groups will continue to receive usual medical care. The study will monitor these groups to see if having an ICD reduces the risk of death. Throughout the study, participants will be followed for up to 10 years, with primary outcomes focused on the percentage of patients alive after 3 years. Researchers will also assess heart-related events, hospitalisations, quality of life using questionnaires, and device-related procedures. Regular monitoring will include clinical evaluations and collection of health data to understand the long-term effects and safety of ICD use in NICM patients.

RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure