Dabrowa Gornicza

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

This trial evaluates different doses of the drug AP31969 to control the rhythm of atrial fibrillation AF and to determine its safety. The study is a randomized Phase 2 trial comparing AP31969 to a placebo in adults diagnosed with paroxysmal or persistent AF who have a measurable AF burden. The study aims to reduce AF burden and improve quality of life using oral medication. Participants are assigned randomly to receive one of several doses of AP31969 100 mg, 200 mg, 350 mg, or later 500 mg or a placebo. All treatments are given as tablets taken orally twice daily for 12 weeks. The study includes three periods screening up to 4 weeks, treatment 12 weeks, and a follow-up period of 30 days. Participants will have an implantable loop recorder to monitor heart rhythm continuously. During the study, participants will attend scheduled visits where blood and urine tests, electrocardiograms, and other assessments will be performed. Researchers will track AF burden, the number of AF episodes, quality of life changes, and episodes of ventricular tachycardia. The total participation time is about 20 weeks, including all study periods, with safety and treatment effects monitored carefully.

Researchers are evaluating two different approaches to treat functional Atrio-Ventricular Block AVB, a heart condition affecting electrical conduction. This trial compares the usual elective pacemaker PM implantation recommended by guidelines with a newer method involving cardiovascular autonomic tests CAT, electrophysiologic assessment EPS, and a procedure called cardioneuroablation CNA. The study aims to see if CNA can safely and effectively treat AVB without the need for a permanent pacemaker, validating current recommendations and exploring an alternative treatment option. The trial will include at least 100 participants aged 18 to 75 with AVB and a positive atropine test. Participants will be randomly assigned to receive either early pacemaker implantation Group A or undergo CATEPS followed by CNA with possible delayed pacemaker implantation if needed Group B. Those opting out of randomization enter a registry with personalized treatment choices. Group A will receive pacemakers with telemonitoring, while Group B will get implantable loop recorders and undergo CNA under general anesthesia. If CNA is unsuccessful, pacemaker implantation may follow. Participants will be involved for at least 12 months, undergoing regular check-ups at baseline, 3, 6, and 12 months. Assessments include ECG telemonitoring, quality of life and symptom questionnaires, and cardiovascular autonomic tests with telemedicine support. Safety will be closely monitored monthly, focusing on major cardiovascular events. The study uses telemonitoring devices and provides 247 contact with specialized medical staff. Data on symptoms, fatigue, depression, and sleep will also be collected to evaluate treatment effects comprehensively.

Researchers are investigating the best way to treat patients with multivessel coronary artery disease or left main narrowing who experience symptoms of acute ischemia, specifically those with non-ST-segment elevation acute coronary syndrome NSTE-ACS. This trial compares two treatments percutaneous coronary intervention PCI with drug-eluting stents and coronary artery bypass grafting CABG. The study aims to understand which method offers better outcomes for patients with complex coronary artery disease who need early invasive treatment. The study enrolls patients with multivessel disease or left main coronary artery disease, eligible for invasive treatment and with a Syntax Score below 33. Participants will be randomly assigned to receive either PCI, involving fractional flow reserve or iFR measurements and optimized stent implantation, or CABG surgery, performed with techniques including on-pump or off-pump methods. Treatment decisions involve a Heart Team consultation, and both approaches aim for complete revascularization. The trial will follow patients over time to compare outcomes. Participants will have follow-up visits including cardiac echocardiography and stress tests after hospitalization. The study will monitor major adverse cardiac and cerebral events MACCE, serious adverse events, procedural complications, cost effectiveness, and heart function over one year and beyond. Secondary outcomes include bleeding, atrial fibrillation, heart failure, rehospitalization, and quality of life. The total study duration extends until 2030, with primary outcome assessment at one year.