Bridgend

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus MACE-PLUS in adults with established atherosclerotic cardiovascular disease ASCVD or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This phase 3 global trial aims to see if this drug can reduce serious heart failure events like hospitalizations, urgent visits, and cardiovascular deaths, while improving heart failure symptoms. The study is event-driven and includes a double-blind period followed by an open-label extension. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial consists of two parts, with Part 1 ending when about 850 primary endpoint events have occurred. The study includes a double-blind treatment period and an open-label extension phase where all participants can receive the drug. During the trial, participants will undergo regular assessments including measurements of heart failure events, cardiovascular deaths, and symptom changes using the Kansas City Cardiomyopathy Questionnaire. Other evaluations include blood pressure, body measurements, kidney function, cholesterol, and blood markers related to heart failure and diabetes. The primary outcome is the time to the first cardiovascular death or heart failure event, measured over up to approximately 35 months. Safety and drug levels will also be monitored throughout the study.

Researchers are evaluating the Heartfelt device, a new passive monitoring system designed to detect early signs of fluid build-up oedema in patients with heart failure by measuring changes in foot and lower leg volume using 3D images. The study aims to determine if adding this device to standard NHS care improves quality of life and reduces heart failure-related events compared to standard care alone. The trial involves 300 participants across multiple NHS hospitals and GP practices in the UK. Participants will be randomly assigned to one of two groups one receiving standard NHS care, which includes regular weight checks and symptom monitoring, and the other receiving the same care plus the Heartfelt device installed at home. The device captures daily images of the feet to track swelling changes without any extra effort from patients. Alerts are sent to clinical teams if important changes are detected, allowing prompt action. Patients in both groups also receive a British Heart Foundation patient booklet to support understanding and self-monitoring. During the study, participants will have their quality of life assessed at multiple points over 12 months alongside tracking heart failure events, hospitalisations, device data availability, medication use, and mortality. The study will also explore how healthcare teams respond to alerts, usability of the device, and its cost-effectiveness. Patient involvement helps ensure the study findings are relevant and useful for future care. The trial runs for 12 months with ongoing monitoring and data collection.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are evaluating the real-world use of nemolizumab for treating moderate-to-severe atopic dermatitis AD in adolescents and adults. This observational study aims to assess the treatments effectiveness through physician evaluations and patient-reported outcomes over six months, providing insight into how the medication performs in everyday clinical practice. Participants receiving nemolizumab as part of their routine care will be observed for about 12 months. Treatment decisions are made by the participants physician before joining the study, with no extra visits or tests beyond usual medical care. A sub-study in Germany and the UK involves daily remote reporting of symptoms such as peak and average itch, sleep disturbance, and pain for the first two weeks. During the study, participants will have regular medical visits as determined by their doctors, with data collected from routine assessments and patient questionnaires. Researchers will measure outcomes like the Investigator Global Assessment and Peak Pruritus Numerical Rating Scale at six months, along with other severity and symptom scores up to 12 months. No additional procedures outside standard care are required, allowing for natural monitoring of treatment effects and safety.