Dabrowa Gornicza

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating the effects and safety of different doses of AP31969, an oral medication, compared to a placebo for controlling the rhythm of atrial fibrillation (AF). This randomized Phase 2 clinical trial focuses on adults diagnosed with paroxysmal or persistent AF, aiming to reduce AF burden — the percentage of time a person has AF — over the course of the study. Participants will be randomly assigned to receive AP31969 in doses of 100 mg, 200 mg, 350 mg, or later 500 mg, or a placebo. All treatments are taken orally twice daily. The study consists of three main periods: a screening phase lasting up to 4 weeks, a 12-week treatment phase, and a 30-day follow-up. During the trial, participants will have a loop recorder implanted to continuously monitor heart rhythm. Throughout the study, participants will attend scheduled visits for assessments including blood and urine tests and electrocardiograms to monitor heart activity. The primary measurement is the burden of atrial fibrillation from week 2 to week 12. The total participation time is about 20 weeks, during which safety and effectiveness of AP31969 will be closely observed.

Researchers are evaluating two treatment methods for patients with functional Atrioventricular Block (AVB): standard elective pacemaker (PM) therapy following guidelines versus a strategy involving cardiovascular autonomic tests, electrophysiologic assessment, and cardioneuroablation (CNA). The study aims to determine if functional AVB can be effectively treated without implanting a pacemaker and to assess the safety and feasibility of CNA, potentially avoiding long-term pacing complications and costs. This trial will also validate European Society of Cardiology recommendations and introduce CNA as a treatment option for functional AVB. The trial will enroll at least 100 participants aged 18 to 75 with indications for elective pacemaker implantation and positive atropine tests. Participants will be randomly assigned to either receive optimized guideline-recommended PM therapy or undergo cardiovascular autonomic testing, electrophysiologic studies, and CNA if appropriate. Those opting out of randomization will enter a registry with individualized treatment options including PM, CNA, or observation. Treatment includes pacemaker implantation or CNA performed under general anesthesia with advanced mapping and vagal nerve stimulation guidance, followed by regular telemonitoring using ECG devices and implantable loop recorders. Participants will be monitored for a minimum of 12 months with scheduled visits at baseline, 3, 6, and 12 months including quality of life and symptom questionnaires, cardiovascular autonomic testing, and telemedical ECG monitoring. Safety will be assessed monthly with monitoring for major adverse cardiovascular events. Data collected will include demographic, clinical, and telemonitoring parameters. Patients can withdraw at any time without affecting their care. This study compares the effectiveness of CNA versus pacemaker therapy over 12 months after device implantation or procedure.

Researchers are exploring the best treatment for patients with multivessel coronary artery disease or left main narrowing who experience symptoms of acute ischemia without ST-segment elevation. This study compares two revascularization strategies: percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Existing guidelines recommend CABG, but recent studies suggest PCI may offer similar long-term outcomes with fewer immediate risks. The trial aims to test whether PCI is not worse than CABG in terms of major cardiac and cerebral events like death, heart attack, or stroke within one year after treatment. Participants will be randomly assigned to either PCI or CABG. PCI involves using modern drug-eluting stents along with assessments like fractional flow reserve and intravascular imaging to optimize the procedure. CABG will be performed using standard surgical techniques, including the use of the internal mammary artery. Both treatments aim to achieve complete revascularization. The study includes patients with a Syntax Score below 33, indicating moderate complexity of coronary disease. In centers without surgical facilities, heart team consultations will occur via videoconference. During the study, patients will be closely monitored with follow-up visits that include cardiac ultrasound and stress tests. Researchers will assess outcomes like death, heart attacks, strokes, revascularization needs, heart function, bleeding events, new heart rhythm problems, heart failure, hospital readmissions, quality of life, and cost effectiveness. Patients will also receive standard secondary prevention care, including cardiac rehabilitation. The total follow-up period includes one year after the procedure to evaluate major adverse cardiac and cerebral events.