Grodzisk Mazowiecki

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.

Researchers are studying sleep patterns in people with paroxysmal atrial fibrillation who are scheduled for pulmonary vein isolation, a procedure to control heart rhythm. The study aims to see how sleep parameters, especially the apnea-hypopnea index AHI, change during treatment. This observational study uses polygraphy to monitor sleep without affecting patients regular care. Participants will undergo four sleep studies using polygraphy to record pulse oximetry, heart rate, chest and abdominal movements, and nasal airflow. Two studies occur before the ablation procedure, spaced at least 7 days apart, and two after the procedure, starting one month later, also spaced by at least 7 days. The ablation itself is a routine clinical procedure and not part of the study. During the study, participants will receive standard care including lifestyle advice and therapies as needed. Researchers will track sleep parameters before and after ablation using certified sleep-monitoring devices. The main outcome is the change in AHI from baseline over about one year. Participation involves non-invasive sleep monitoring and does not interfere with usual treatment, with data protected according to privacy regulations.

Researchers are evaluating the safety, effectiveness, and clinical outcomes of percutaneous coronary intervention PCI for chronic total occlusions CTO in patients treated in routine clinical practice in Poland. The study seeks to understand procedural success rates, complications, and how different PCI strategies, intravascular imaging, mechanical support, and artificial intelligence analysis impact patient outcomes and quality of life. It also focuses on outcomes in various patient subgroups, including those with complex medical histories. This observational study enrolls patients undergoing CTO PCI as part of their standard care in a national, multicenter registry. Clinical, procedural, and follow-up data are collected prospectively to assess real-world outcomes. The study compares PCI performed with and without intravascular imaging and evaluates different treatment strategies such as drug-coated balloons, drug-eluting stents, and hybrid approaches. It also monitors the use of mechanical circulatory support and applies AI-based analysis of baseline electrocardiograms for outcome prediction. Participants will be followed to measure technical success of the procedure and monitor procedural details such as procedure time, fluoroscopy time, radiation dose, contrast volume, and procedural complications within one day. Additional outcomes include target lesion failure during hospital stay and up to one year, as well as mortality at one year. The study collects information on post-procedure cardiac injury markers and quality-of-life improvements, with data gathered throughout routine clinical care over the follow-up period.

This trial is a rollover study for adults who previously participated in specific Incyte-sponsored clinical trials involving the drug povorcitinib. It focuses on people with Hidradenitis Suppurativa HS, a condition being studied to better understand the long-term safety and effects of continuing povorcitinib treatment. The purpose is to monitor participants who have already benefited from povorcitinib in earlier studies, now entering an extended phase to further evaluate safety and treatment outcomes. Participants will continue taking povorcitinib orally, following the same dose and schedule they had in their original parent study. This study does not test new doses or compare treatments but observes continued use of the drug under the established regimen. The study may last for up to approximately three years, reflecting extended monitoring rather than initial treatment phases. During the study, participants will attend scheduled visits for assessments, including tracking any treatment-emergent adverse events and measuring symptom counts related to HS. Researchers will collect safety data over the long term and observe clinical responses. Participants must adhere to study procedures and avoid pregnancy or fathering children as required. The study aims to provide detailed safety information over an extended period while participants remain on the drug regimen from their original trial.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.