Bernau Im Schwarzwald

Researchers are evaluating the safety and effectiveness of the AccuCinch Ventricular Restoration System in patients with heart failure who have a reduced ejection fraction, a condition where the heart does not pump blood efficiently. This international, randomized, open-label study involves patients diagnosed with heart failure and dilated cardiomyopathy, aiming to compare this device plus standard medical treatment against standard treatment alone. The study focuses on improving heart function and patient quality of life. Participants are randomly assigned to two groups: one receiving the AccuCinch device along with guideline-directed medical therapy, and the other receiving only the medical therapy. About 200 patients will be in each group. Medical treatments are optimized according to current heart failure guidelines. The study includes multiple assessments over time to monitor the device's impact and the patients' heart health. Throughout the study, participants will undergo various tests and evaluations including quality of life questionnaires, six-minute walk tests, and monitoring for major adverse events related to the device or femoral artery access. The study will track outcomes for up to 365 days, measuring deaths, heart failure hospitalizations, and changes in heart function scores. Participants must attend follow-up visits and comply with testing schedules to assess the safety and benefits of the treatment.

The MobiDig trial is designed to study a mobile phone application aimed at patients with heart failure treated in certified Heart Failure Unit centers in Berlin and Brandenburg. The study focuses on evaluating the app's effects on quality of life, heart failure symptoms, and the disease's progression. It also investigates how well patients accept and use the app, their adherence and user behavior, and the potential to implement this app permanently within national heart failure networks. The application includes several modules: information and education about heart failure; a vital sign diary that can be sent to the certified Heart Failure Unit; a pedometer with individualized step goals and cardiac home training videos; and a frequently asked questions section with a connection to a certified Heart Failure Unit provider via a heart failure hotline. Participants will use this app as part of their care during the study. Participants will be monitored over a 3-month period for various outcomes including acceptance of the application, changes in quality of life and heart failure symptoms, patient-reported outcomes, six-minute walk distance, daily walking distances, heart failure biomarkers, and the number and length of hospitalizations. These assessments will be compared at the start and after 3 months to evaluate the app's impact and safety.