Search Bar & Filters
Found 5 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
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.
Actively Recruiting
This research aims to assess sleep parameters using polygraphy in patients with paroxysmal atrial fibrillation who are scheduled for pulmonary vein isolation. The study focuses on understanding changes in sleep, especially the apnea-hypopnea index (AHI), during rhythm-control therapy. Atrial fibrillation is a common heart rhythm problem often linked with obstructive sleep apnea, and this study explores how treatment affects sleep quality. Patients will undergo four polygraphic sleep studies: two before and two after their atrial fibrillation ablation. These studies will be spaced at least 7 days apart, with the post-ablation studies starting one month after the procedure. The polygraphy will record pulse oximetry, heart rate, chest and abdomen respiratory movements, and nasal airflow using specialized equipment. The ablation procedure itself is routine care and not part of the study intervention. Participants will be monitored through these sleep studies and standard clinical care. Researchers will analyze changes in the AHI, oxygen levels, heart rate, and breathing patterns over about one year from baseline. The study involves approximately 100 participants and aims to provide insights into how rhythm-control therapy impacts sleep in patients with atrial fibrillation. Participation is voluntary and does not interfere with usual treatment.
Actively Recruiting
This research aims to evaluate the safety, effectiveness, and clinical results of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) in patients treated in routine clinical practice in Poland. It focuses on rates of procedural success, complications, different PCI strategies and techniques, and the impact of artificial intelligence-based analysis on predicting outcomes and quality of life. The study includes a variety of patient subgroups, including those at higher risk due to conditions like low ejection fraction or diabetes. Patients receiving CTO PCI as part of their usual medical care will be enrolled in a national, multicenter registry. The study will observe different treatment strategies such as drug-coated balloons, drug-eluting stents, and hybrid approaches. It will also assess the use of intravascular imaging and mechanical circulatory support during PCI, examining how these factors relate to clinical outcomes. Participants will have clinical, procedural, and follow-up data collected to assess real-world results. Researchers will monitor procedural success within one day and track complications and cardiac injury markers after treatment. The study will analyze quality-of-life improvements and outcomes in high-risk groups over time, providing a comprehensive view of CTO PCI in contemporary practice.
Actively Recruiting
This research focuses on participants with Hidradenitis Suppurativa (HS) who have previously taken part in specific Incyte-sponsored clinical trials of povorcitinib. The study is a Phase 3b rollover trial designed to continue monitoring these individuals to gather further information on the treatment. It aims to evaluate the safety of povorcitinib over an extended period, including the proportion of participants experiencing treatment-emergent adverse events for up to about three years. Participants will continue taking the study drug povorcitinib orally as specified by the study protocol. This rollover study includes individuals who completed the treatment period in the parent studies without safety or tolerability issues and who showed clinical benefit from povorcitinib. During this study, participants will follow the protocol-defined dosing and procedures while avoiding pregnancy or fathering children as required. Throughout the study, participants will attend scheduled visits and assessments to monitor their health and treatment effects. Researchers will track adverse events and adherence to the treatment plan. The study involves ongoing evaluation for up to approximately three years to ensure safety and collect important long-term data on povorcitinib use in this group of patients with HS.