Ashford

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

Researchers are evaluating the safety and effectiveness of whole-body hypothermia for newborn babies with mild hypoxic ischaemic encephalopathy. This phase III randomised controlled trial aims to determine whether cooling the whole body to 33.5.5C within six hours after birth and continuing for 72 hours improves cognitive development at around two years of age compared with maintaining normal body temperature. The study also seeks to assess the economic value of cooling therapy for mild encephalopathy within the healthcare system. Babies born at or after 36 weeks with signs of birth asphyxia or acidosis will be randomly assigned to receive either whole-body hypothermia or targeted normothermia. Cooling will be applied using a servo-controlled machine in neonatal intensive care units, maintaining a rectal temperature of about 33.5C for 72 hours. The control group will have their body temperature kept at normal levels 37C for the first 80 hours, with any fever carefully treated. Babies born at non-cooling centers will be transferred to specialized units for treatment. During the study, participants will undergo brain monitoring, MRI scans before discharge, and follow-up developmental assessments at 24 months using the Bayley Scales of Infant and Toddler Development IV. Additional evaluations will include neurological exams, motor function assessments, vision and hearing tests, and parent-completed questionnaires. Researchers will collect detailed clinical data from birth through hospital stay, aiming to compare cognitive outcomes and safety measures between the two groups over the study period.

This research investigates whether personalized medical treatment guided by a special diagnostic procedure during invasive coronary angiography can improve symptoms, wellbeing, cardiovascular risk, and clinical outcomes in patients with angina but no significant blockage in their coronary arteries. It focuses on patients with ischaemic heart disease, particularly those with angina without obstructive coronary artery disease INOCA, a condition affecting the small vessels of the heart. The trial builds on earlier pilot studies that suggested this approach could improve quality of life and symptom control by tailoring diagnosis and treatment more precisely. Participants undergo functional coronary angiography with a guidewire-based interventional diagnostic procedure IDP that measures coronary vascular function to classify patients into specific diagnosis groups, such as microvascular or vasospastic angina. Eligible patients are randomized into two groups one where IDP results are disclosed to clinicians to guide treatment, and another where IDP is performed but results are hidden, with care based on standard angiography and clinical information. Both groups receive medical therapy and lifestyle advice based on their diagnosis. The study also includes a registry for patients with obstructive disease who are not randomized. During the study, participants complete symptom questionnaires like the Seattle Angina Questionnaire to assess their angina symptoms and quality of life over at least 12 months. Researchers monitor health status, clinical outcomes, safety, and health economics, with ongoing follow-up planned for up to 10 years. Both patients and their usual care clinicians are blinded to the group allocation, but informed about the diagnosis to guide treatment. The trial aims to enroll 1500 participants across multiple centers in Europe, assessing the feasibility and impact of this stratified medicine approach.

Researchers are exploring how the gut microbiome affects people with gallstone disease. This observational study aims to find out whether changes in the gut microbiome relate to complications like pancreatitis and acute cholecystitis, and how the microbiome shifts after gallbladder removal cholecystectomy. The study focuses on adults diagnosed with gallstone disease and seeks to understand these relationships to improve patient outcomes. Participants will provide stool samples at specific times at diagnosis, before surgery if needed, shortly after surgery, and then at 6 months and 3 years following cholecystectomy. Additional stool samples will be collected if participants are hospitalized with complications from gallstone disease. They will also complete 3-day food diaries to help researchers analyze the gut microbiome. During the study, researchers will collect medical data from patient records, including clinical history, diagnostic tests, blood results, and imaging done as part of routine care. Stool samples will be mailed to the research team for analysis of bacterial DNA profiles over up to 3 years. The study monitors how microbiome changes relate to complications before and after surgery, with the goal of identifying factors that affect patient health and treatment outcomes.

Researchers are evaluating the Heartfelt device, a new passive monitoring system that detects early signs of fluid build-up in patients with heart failure by measuring changes in foot and lower leg volume using 3D images. The study aims to see 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 from multiple NHS hospitals and GP practices across the UK and uses a randomized crossover design. Participants will be randomly assigned to receive either standard NHS care, which includes regular weight checks and symptom monitoring, or standard care plus the Heartfelt device installed at home. The device captures daily images of the feet to track swelling without extra effort from the user. Alerts triggered by important changes are sent to the clinical team for prompt action. Both groups receive a patient booklet from the British Heart Foundation to support self-monitoring and understanding of heart failure. During the study, participants quality of life will be assessed using questionnaires at baseline and at 3, 6, 9, and 12 months. The study will also monitor hospitalizations, deaths, medication adherence, and the availability of daily device data. Researchers will evaluate how the clinical teams respond to alerts, the ease of device use, and its cost-effectiveness. The total participation period covers 12 months of monitoring and data collection.

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction MI specifically ST-segment elevation MI STEMI or non-ST-segment elevation MI NSTEMI who also have multivessel coronary artery disease CAD and have undergone successful treatment of the culprit lesion with Percutaneous Coronary Intervention PCI. The study aims to compare physiology-guided complete revascularization to angiography-guided complete revascularization, focusing on both efficacy and safety outcomes. Participants are randomly assigned to one of two groups. One group receives physiology-guided PCI where the function of non-culprit lesions NCLs is assessed using resting full-cycle ratio RFR or fractional flow reserve FFR, with PCI performed on lesions meeting specific thresholds. The other group undergoes angiography-guided PCI, receiving routine staged PCI on all qualifying NCLs identified before randomization. Both approaches follow local practice standards for PCI. During the study, researchers monitor participants for a minimum of two years to assess the time to first occurrence of major cardiovascular events, including cardiovascular death, new MI, or ischemia-driven revascularization, as well as safety outcomes like significant bleeding, stroke, stent thrombosis, or kidney injury related to contrast use. The trial also includes an observational imaging study using optical coherence tomography in a subset of patients. Follow-up assessments will enable evaluation of both efficacy and safety over the study period.

Spontaneous coronary artery dissection SCAD is a recognized cause of non-atherosclerotic acute coronary syndromes, mainly affecting young women without typical risk factors. Researchers are building the first pan-European SCAD registry to improve understanding of this conditions diagnosis and management, inform guidelines, educate clinicians, and promote research. This international, multicenter, observational study includes both retrospective and prospective patient data. The study collects data without any treatment interventions, enrolling at least 500 new patients and 500 historical cases from about 30 countries and 120 sites. Patient information is gathered from their first SCAD event, at enrollment, and then yearly for up to five years or until study completion. There are no study drugs or procedures involved as it is purely observational. Participants will provide data at multiple time points including baseline and yearly follow-ups for up to five years. Researchers will review patient status, vital signs, recurrent SCAD events, imaging results, medications, menstrual and obstetric history, and discharge details. Additional information on procedures, other coronary events, symptoms, pregnancy and hormonal therapy, exercise habits, mental health, and employment after SCAD will also be collected. This allows a comprehensive understanding of SCAD over time.

This research aims to evaluate two types of ostomy seals or rings in patients who have recently undergone ostomy surgery. It focuses on preventing and managing complications related to the skin around the stoma, known as peristomal skin complications PSCs. The study is sponsored by Hollister Incorporated and involves post-operative patients with colostomy, ileostomy, or urostomy, assessing how these devices perform in real-world use. Participants will be randomly assigned to use either an absorptive ostomy seal or an ostomy ring containing Aloe. These devices are applied at the first pouch change following surgery or up to four days after the operation. The study treatment period lasts for nine weeks, during which patients use the assigned seal or ring as part of their ostomy care. The trial compares the two devices to monitor skin complications and other related outcomes. During the study, participants will be followed from enrollment through the nine-week treatment phase with regular assessments. Researchers will track skin complications using the Ostomy Complication Severity Index OCSI, including measures of leakage, moisture, skin conditions, and patient and clinician satisfaction. The study also collects data on usage patterns, healthcare visits related to the ostomy, and costs associated with the seals or rings. The overall goal is to understand the devices impact on skin health and patient experience after ostomy surgery.