Ashford

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

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.

Researchers are evaluating whether avoiding further axillary treatment after neoadjuvant chemotherapy (NACT) is as effective as standard axillary treatment for patients with early stage breast cancer who initially had cancer in the lymph nodes confirmed by needle biopsy but show no residual cancer in the lymph nodes after NACT. The study aims to determine if skipping axillary lymph node dissection (ALND) or axillary radiotherapy (ART) affects disease free survival (DFS) and whether it reduces the risk of lymphoedema five years after treatment. This phase 3, open-label, randomized trial includes patients with T1-3N1M0 breast cancer and confirmed nodal metastases who have undergone sentinel node biopsy removing at least three lymph nodes post-NACT.

Researchers are evaluating the safety and effectiveness of whole-body hypothermia treatment in newborn babies diagnosed with mild hypoxic ischaemic encephalopathy (HIE). This phase III randomized controlled trial aims to determine whether cooling babies to 33.57b0C within six hours of birth for 72 hours improves cognitive development at two years of age compared to maintaining normal body temperature (normothermia). The study also assesses the cost-effectiveness of cooling therapy to help guide national and international treatment guidelines and standardize care across the NHS. Babies born at or after 36 weeks with specific signs of birth asphyxia or acidosis are randomly assigned to either whole-body hypothermia or targeted normothermia groups. The hypothermia group will have their body temperature lowered and maintained at 33.57b0C using a cooling machine for 72 hours in a neonatal intensive care unit. The normothermia group will have their temperature maintained at 377b0C with treatment for any fever using standard protocols. If babies in the normothermia group develop seizures and worsen to moderate HIE, they may receive cooling treatment as part of clinical care. Conventional MRI scans will be performed before discharge. Participants will be followed up at 24 months of age (7 months) using the Bayley Scales of Infant and Toddler Development IV to measure cognitive, language, and motor skills. Additional neurological exams, including assessments for cerebral palsy, vision, and hearing, will be conducted. Parents will complete questionnaires about their child's development. Researchers will collect detailed clinical data from birth through follow-up to evaluate safety and developmental outcomes. Babies who die or cannot complete assessments due to severe disability will be assigned specific scores to reflect outcomes.

Researchers are studying patients with known or suspected angina who do not have obstructive coronary artery disease to see if a special diagnostic test can help guide personalized treatment. This condition includes ischaemic heart disease, microvascular angina, and vasospastic angina. The trial builds on earlier research suggesting that tailoring treatment based on coronary vascular function tests may improve symptoms and quality of life. This large, multicentre, blinded, randomized study aims to confirm these findings and assess effects on health and wellbeing over a longer period. Participants undergo invasive coronary angiography along with an adjunctive interventional diagnostic procedure (IDP) that measures coronary vascular function using a guidewire technique. Patients with no significant artery blockage are randomized into two groups: one where IDP results are disclosed to guide treatment decisions, and a control group with concealed results receiving standard care. Those with abnormal vascular function in the intervention group may have repeated assessments to tailor medications, such as calcium channel blockers. Patients with obstructive artery disease or other exclusions may join a registry for follow-up and assessment. Throughout the study, participants complete questionnaires about angina symptoms, quality of life, activity levels, treatment satisfaction, and pain. Researchers monitor clinical outcomes for at least 12 months, including major cardiovascular events. The study also evaluates the safety and usefulness of the diagnostic procedure in multiple hospitals across Europe. Blood samples are collected to explore disease mechanisms. Participants and their doctors remain blinded to group assignments, but diagnoses are shared to help guide care following current guidelines.

Researchers are investigating the role of the gut microbiome in adults diagnosed with gallstone disease. The study aims to explore whether differences in the gut microbiome are linked to complications such as pancreatitis and acute cholecystitis, and to observe changes in the gut microbiome after gallbladder removal surgery (cholecystectomy) and how these relate to patient outcomes. This is a prospective observational study involving 75 adult patients diagnosed at East Kent University Hospitals. Participants will provide stool samples at specific times: at diagnosis, before surgery, immediately after surgery, and at intervals of 6 months and up to 3 years post-cholecystectomy. Stool samples may also be collected if patients are readmitted with complications related to gallstone disease. Along with stool samples, participants will complete a 3-day food diary. Clinical data including medical history, imaging, blood results, and hospital readmissions will be collected from patient records. During the study, researchers will analyze bacterial DNA profiles from stool samples to understand microbiome changes and their relation to complications and outcomes. Patient monitoring includes clinical assessments and reviewing hospital data for complications. The study will last up to 3 years from surgery, helping to identify microbiome patterns that may influence gallstone disease progression and recovery after surgery.

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction (MI), including both ST-segment elevation MI (STEMI) and non-ST-segment elevation MI (NSTEMI), who also have multivessel coronary artery disease (CAD). The trial compares physiology-guided revascularization, which uses specific measurements to decide treatment, with angiography-guided revascularization, which relies on imaging. The study aims to determine if the physiology-guided approach is not worse than the angiography-guided method in preventing cardiovascular death, new MI, or ischemia-driven revascularization, and whether it is better at reducing safety issues like bleeding, stroke, or kidney injury. Participants undergo procedures to treat non-culprit lesions (NCLs) using either physiology guidance or angiography guidance. In the physiology-guided group, percutaneous coronary intervention (PCI) is performed on lesions with resting full-cycle ratio (RFR) of 0.89 or less or fractional flow reserve (FFR) of 0.80 or less, according to local practice. The angiography-guided group receives PCI based on imaging assessments following local practice. The study includes an observational imaging sub-study using optical coherence tomography (OCT) for a subset of patients. Participants are involved for a minimum of two years, during which researchers monitor the time to first cardiovascular events such as death, new MI, or additional revascularization, along with safety events like bleeding or stroke. The study includes regular evaluations and follow-up to assess these outcomes, ensuring comprehensive safety and efficacy data collection in this patient population.

Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndromes that mainly affects young women without typical risk factors for atherosclerosis. Recent advances in understanding SCAD have come from regional and national registries, but there is a need for international collaboration to better understand diagnosis, treatment, and outcomes. This study aims to create the first pan-European SCAD registry to improve knowledge, guide clinical practice, and support research. This is an observational, multicenter, international retrospective and prospective cohort study involving at least 500 patients recruited prospectively and 500 historical cases. Data will be collected from patients diagnosed with SCAD within the past 10 years, including information from the first SCAD event and yearly follow-ups up to 5 years after enrollment. Approximately 30 countries and 120 sites will participate, and no treatments or interventions will be given as part of the study. Participants will have their medical records and coronary angiographic images reviewed at baseline and will be followed annually for up to 5 years. Information collected will include patient status, vital signs, recurrent SCAD events, imaging results, medications, menstrual and obstetric history, and discharge details. The study aims to gather comprehensive data to better understand SCAD management and long-term outcomes.

Researchers are evaluating whether stopping enteral feeds around the time of blood transfusions in very premature infants born before 30 weeks of gestation can reduce the risk of Necrotizing Enterocolitis (NEC). NEC is a serious intestinal disease that affects mostly preterm infants and can cause severe complications or death. This international trial compares two common care practices in Canada and the UK to see if either approach leads to better outcomes for these vulnerable infants. The trial includes two groups: one group will have all enteral feeds stopped starting 4 hours before a packed red cell transfusion, continuing during the transfusion, and until 4 hours after it ends. The other group will continue receiving feeds during the transfusion as they were before. Infants will stay on their assigned feeding strategy until they reach 34 weeks and 6 days of gestational age. Throughout the study, researchers will monitor infants for the development of NEC up to 40 weeks postmenstrual age. They will review medical records and track feeding and transfusion details to measure outcomes. This trial aims to provide clear evidence on whether withholding feeds around transfusions can help prevent NEC and improve health in very premature infants.