Craigavon

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.

Heart failure is a common condition in the United Kingdom, where many patients depend on family members or friends to help care for them. These caregivers often face challenges and stress due to their role, which can affect their own mental and physical health. The Heart Failure Carer Support Programme HELP is the first intervention developed in the UK to support these carers by helping them care for themselves and the patients they assist. The study aims to find the best way to provide HELP across the UK and measure its effects on both carers and patients. HELP is delivered by heart failure nurses to about 180 informal carers across three UK locations. The programme consists of six weekly online support group sessions lasting one hour each, led by specialist nurses via video calls. Carers also receive an educational booklet and access to a website for additional guidance. Patients supported by these carers, also around 180 individuals, will provide information to assess how HELP affects both carers and patients over time. Participants will provide information at different times before the programme starts, during the six weeks of HELP, immediately after finishing, and six months later. Researchers will collect data through interviews, logs, and questionnaires to understand how well HELP is delivered and what factors influence its success. They will also measure hospital admissions, doctor visits, and quality of life for patients, as well as burden, preparedness, and quality of life for carers. The study will last up to one year, including monitoring costs and long-term effects.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Acute respiratory infections ARI are a common cause of hospital admissions and antibiotic use, caused by various pathogens including viruses like influenza and coronaviruses. This observational study aims to describe routine diagnostic and treatment practices for ARI and to characterize the adult patient population presenting with ARI in acute hospital settings across Europe. The study also seeks to understand the causes of ARI in these patients and variations in clinical outcomes. The study collects data from adults with ARI who visit emergency rooms or acute medical assessment units, including those admitted to hospital and those discharged the same day. Diagnostic methods such as laboratory and point of care tests, as well as pharmacological treatments like antibiotics and antivirals, are recorded. A subset of participants will have a respiratory sample taken within 24 hours to identify pathogens using molecular methods. Participants will undergo data collection about their clinical condition, laboratory tests, and treatments received. Researchers will track the use of microbiology and virology tests, antibiotic and antiviral treatments, clinical outcomes, hospital and ICU stays, and mortality up to 28 days after admission or discharge. Patient demographics, symptoms, comorbidities, physiological measurements, and ARI causes will also be studied. The study is ongoing and observational, with no direct interventions beyond data collection.

Idiopathic pulmonary fibrosis IPF is a progressive lung disease causing scarring that leads to coughing and breathlessness. Many IPF patients also have reflux disease, where stomach acid can damage the lungs. This research aims to find out if treating IPF patients with proton pump inhibitors PPIs, which reduce stomach acid, can slow down the progression of IPF. The trial is a randomized, placebo-controlled study involving 298 IPF patients across about 37 UK hospitals. Participants will be randomly assigned to take either lansoprazole a PPI or dummy tablets twice daily for 12 months. They will start weekly breathing tests at home using equipment provided and, if they have a cough, use a device to count coughs over 24 hours. Participants will complete questionnaires about coughing, breathlessness, sleep habits, and overall health. Some will also wear activity and sleep monitors during cough monitoring sessions. Dose reduction is allowed if side effects occur. During the study, patients will complete regular questionnaires and provide blood samples for safety checks at 3, 6, 9, and 12 months. Weekly home spirometry will continue for the full year. Researchers will track lung function, cough frequency and severity, breathlessness, quality of life, sleep quality, reflux symptoms, and hospital-free survival. Remote and in-person visits are possible, and participants will receive training on study procedures. The primary outcome is the change in lung function 12 months after starting treatment.