Comparing Implantable Defibrillators Versus No Defibrillators in Adults with Non-Ischemic Cardiomyopathy and Severe Heart Failure Using Heart MRI

What this Trial Is About

This research is investigating the use of Implantable Cardioverter-Defibrillators ICDs in adults diagnosed with heart failure caused by Non-Ischemic Cardiomyopathy NICM, a condition where heart failure is not due to blocked arteries. The study aims to compare the all-cause mortality rates between patients who receive an ICD and those who do not, over a period of 36 months and extending up to 10 years. This trial addresses ongoing questions about whether ICDs benefit patients with NICM, especially given recent findings that many patients with ICDs do not experience serious heart rhythm problems. Participants are randomly assigned to one of two groups one group will have an ICD or Cardiac Resynchronisation Therapy Defibrillator CRTD implanted, which are devices designed to detect and correct dangerous heart rhythms. The other group will not receive an ICD but may have an Implantable Loop Recorder or a Cardiac Resynchronisation Therapy Pacemaker CRTP, alongside their usual medical care. The study will monitor both groups to determine if ICD implantation improves survival compared to no ICD over the study period. Throughout the trial, participants will be regularly evaluated with health assessments including quality of life questionnaires and monitoring of heart-related events such as hospitalizations and arrhythmias. Researchers will track outcomes like survival percentage, heart rhythm events, and device-related procedures over 3 years, with some outcomes also measured at 5 and 10 years. The study includes close observation of safety and effectiveness, with participants followed to understand long-term impacts of ICD therapy in this patient group.

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