Guilhufe

Researchers are studying whether ziltivekimab can help people living with heart failure and inflammation. The trial focuses on participants with heart failure who have mild to preserved heart function and systemic inflammation. This phase 3 study compares ziltivekimab, a new medicine not yet approved, to an inactive placebo to understand its effects on heart failure symptoms and physical function. Participants will receive either ziltivekimab or a matching placebo administered as a subcutaneous injection once a month for 12 months. Both groups will continue their standard heart failure care alongside the study treatment. The treatment assignment is randomized, meaning participants have an equal chance of receiving the active medicine or placebo, and the study uses a quadruple masking method to keep participants and researchers unaware of the treatment given. During the study, participants will be monitored for changes in heart failure symptoms using tools like the Kansas City Cardiomyopathy Questionnaire and a 6-minute walk test. Researchers will also assess inflammation markers, heart function measures, and quality of life at regular intervals over the 12 months. The study aims to observe the effects of ziltivekimab compared to placebo over this period, with safety and symptom improvement carefully tracked.

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk AS, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.