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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the impact of implantable cardioverter-defibrillators ICDs on patients who have survived a myocardial infarction heart attack and have a severely reduced left ventricular ejection fraction LVEF of 35% or less. This group is at increased risk of sudden cardiac death caused by dangerous heart rhythms. Past landmark trials showed ICDs improved survival, but advances in medical therapy have changed patient outcomes, prompting the need to reassess the benefits and risks of ICDs alongside current optimal treatments. In this randomized trial, participants receive optimal medical therapy OMT based on European Society of Cardiology guidelines for managing heart failure and chronic coronary syndromes. One group will also receive an ICD device, while the other group will not. The study compares outcomes between these two groups to determine if OMT without ICD is not worse than OMT with ICD in preventing death. The trial includes patients with symptomatic heart failure and reduced LVEF after a myocardial infarction. Participants will be followed over time with regular evaluations to monitor health and outcomes. Researchers will measure the time from randomization to death from any cause as the primary outcome, with additional assessments including cardiovascular death, sudden cardiac death, hospital readmissions, length of hospital stays, and quality of life over a year. The study is event-driven and expects to observe outcomes about 15 months after the last participant is enrolled. Safety and effectiveness of treatments will be carefully monitored throughout.
Actively Recruiting
This trial investigates a new therapy approach for adults with severe sepsis and septic shock. Researchers are studying whether adding an immune cell perfusion system, called ARTICE, to the standard treatment helps improve organ function by supporting the weakened immune system in these critically ill patients. Participants are randomly assigned to one of two groups one receiving the ARTICE immune cell extracorporeal therapy alongside standard care, and the other receiving standard care alone. ARTICE uses purified granulocyte concentrate in an extracorporeal treatment system. The therapy is given shortly after diagnosis of septic shock, which must be recent, within 48 hours before starting the study. During the study, participants will be closely monitored with various assessments including safety checks for serious side effects from day 2 to day 28. Researchers will also track survival rates, organ function scores, inflammatory markers, time to organ recovery, length of ICU and hospital stays, days free from mechanical ventilation and antibiotics, and quality of life up to 90 days. The total observation includes early safety and longer-term outcomes to evaluate the therapys impact.