Hardwick

Researchers are evaluating the Heartfelt device, a new passive monitoring system that detects early signs of fluid build-up in patients with heart failure by measuring changes in foot and lower leg volume using 3D images. The study aims to see if adding this device to standard NHS care improves quality of life and reduces heart failure-related events compared to standard care alone. The trial involves 300 participants from multiple NHS hospitals and GP practices across the UK and uses a randomized crossover design. Participants will be randomly assigned to receive either standard NHS care, which includes regular weight checks and symptom monitoring, or standard care plus the Heartfelt device installed at home. The device captures daily images of the feet to track swelling without extra effort from the user. Alerts triggered by important changes are sent to the clinical team for prompt action. Both groups receive a patient booklet from the British Heart Foundation to support self-monitoring and understanding of heart failure. During the study, participants quality of life will be assessed using questionnaires at baseline and at 3, 6, 9, and 12 months. The study will also monitor hospitalizations, deaths, medication adherence, and the availability of daily device data. Researchers will evaluate how the clinical teams respond to alerts, the ease of device use, and its cost-effectiveness. The total participation period covers 12 months of monitoring and data collection.

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.