Aue Bad Schlema

Researchers are studying patients who have survived a heart attack (myocardial infarction) and are at higher risk for sudden cardiac death caused by dangerous heart rhythms. This study focuses on patients with a severely reduced heart function measured by left ventricular ejection fraction (LVEF) of 35% or less. Previous landmark trials showed that implantable cardioverter-defibrillators (ICDs) improved survival compared to medical therapy alone, but since then, new medications have decreased sudden death rates and the need for ICD therapy. Because ICDs carry risks and costs, this study aims to compare modern optimal medical therapy (OMT) alone versus OMT with ICD implantation to see if medical therapy without ICD is not worse for patient survival. Participants will be divided into two groups: one receiving OMT only and the other receiving OMT plus an ICD device. The ICD options include transvenous ICDs, subcutaneous defibrillators, or a newer extravascular ICD with substernal lead placement. OMT will follow current European guidelines for managing coronary syndromes and heart failure. The study is designed to assess outcomes over time from the point of randomization. During the study, researchers will track survival by measuring the time until death from any cause, expecting about 15 months of follow-up after the last participant joins. Patients must have a history of heart attack at least three months prior, symptomatic heart failure, and have been on OMT for at least three months before enrollment. Safety and effectiveness of treatments will be monitored closely throughout the study period.

Researchers are evaluating a new therapy called ARTICE for patients with severe sepsis and septic shock. The study focuses on improving impaired organ function by supporting the immune system of septic shock patients. This is a Phase 2 trial testing the safety and tolerability of ARTICE, which involves treating patients who have septic shock requiring vasopressor support and elevated blood lactate levels despite fluid resuscitation. The treatment involves an extracorporeal immune cell perfusion system using purified granulocyte concentrate. Participants are randomly assigned to receive this ARTICE therapy in addition to standard care. The treatment aims to enhance immune competence. To be eligible, patients must have septic shock for no longer than 48 hours, have central venous and arterial lines in place, and meet other specific clinical criteria. During the study, patients are monitored closely for safety from Day 2 through Day 28, focusing on any serious adverse events. The study includes assessments of organ function and immune response as well as standard clinical monitoring. Participation requires informed consent or appropriate surrogate consent and is limited by strict inclusion and exclusion criteria to ensure patient safety and data reliability.