Basildon

Researchers are studying patients with cirrhosis caused by alcohol-related or metabolic dysfunction-associated steatotic liver disease MASLD. The trial aims to evaluate whether taking capsules containing faecal microbiota from healthy donors can reduce infections and mortality in these patients. This Phase 3 trial follows earlier research that showed faecal microbiota transplantation FMT delivered via endoscopy was safe and feasible, leading to the development of capsules for easier treatment administration. Participants will be randomly assigned to receive either encapsulated FMT or placebo capsules that look identical but contain no active treatment. They will take five capsules every three months over a total period of 21 months or until they develop an infection requiring hospital admission. This double-blind trial means neither participants nor study staff will know which treatment is given. The study will last up to 24 months including follow-up, monitoring effects on infection rates, liver health, immune system function, and antibiotic resistance. Throughout the trial, participants will be regularly assessed for infections, liver disease progression, hospital admissions, quality of life, mental health, alcohol use, and safety of FMT treatment. Laboratory tests will examine immune response and bacterial resistance. The primary outcome is the time until first infection needing hospital care. The study involves detailed monitoring and follow-up visits for up to two years to understand the treatments impact and safety in patients with cirrhosis.

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.

This research aims to evaluate whether using Bioimpedance Analysis BIA can improve fluid management in patients hospitalized with worsening heart failure. The study compares BIA-guided treatment to standard care to see if this approach reduces the need for extra diuretic treatment or rehospitalization within 90 days after discharge. Heart failure affects millions worldwide, and managing fluid levels accurately is a key challenge in preventing hospital readmissions and worsening symptoms. Participants will be randomly assigned to one of two groups. The BIA-guided group will have BIA measurements performed within 24 hours of admission and throughout their hospital stay to guide fluid management and diuretic use. The standard care group will also have BIA measurements at admission and discharge, but these results will not be shared with their care team, who will manage fluid levels based on usual clinical assessments. After discharge, all patients will attend a follow-up visit 2 to 4 weeks later for health checks, blood tests including NT-proBNP, and a quality-of-life questionnaire. During the study, participants will undergo standard clinical exams, blood tests, and questionnaires to assess heart failure symptoms and quality of life. Researchers will track hospital readmissions, need for additional treatment, kidney function, length of hospital stay, and mortality up to 12 months after discharge. The main outcome is the rate of heart failure events within 90 days post discharge. Safety and long-term effects will also be monitored, with data analyzed after all participants have completed follow-up.

Researchers are conducting a multi-centre observational study to better understand giant cell arteritis GCA and polymyalgia rheumatica PMR, conditions mainly affecting people over 50 years old. The study aims to identify genetic factors that influence susceptibility to these diseases to provide new insights into how they develop. It includes both retrospective participants with confirmed diagnoses and prospective participants suspected of having these conditions, with some patients also enrolled in a registry monitoring tocilizumab treatment for relapsing or refractory GCA. The study collects detailed clinical, imaging, and molecular data, including genetic and proteomic analyses, from participants to characterize disease subtypes and impacts. Researchers also assess quality of life through patient-reported outcomes and track long-term prognosis by linking to health records. The study explores environmental factors and co-existing conditions to improve diagnosis, prognosis, and monitoring of disease activity, especially for patients receiving synthetic or biological disease-modifying anti-rheumatic drugs. Participants provide information during baseline assessments, including blood and urine samples for analysis, and complete questionnaires about their symptoms and quality of life. Follow-up occurs through health record review over an average of one year to evaluate diagnosis and disease outcomes. The primary measure is genetic susceptibility, with secondary outcomes focusing on disease characteristics, life impact, diagnosis, and disease activity. The study is sponsored by the University of Leeds and started in 2005, continuing through 2028.

Researchers are evaluating the safety and performance of remote monitoring functions in ALIZEA, BOREA, and CELEA pacemakers for patients with bradycardia. This observational clinical investigation focuses on the devices Right Atrial Autothreshold RAAT, Right Ventricular Autothreshold RVAT, and remote alert features. The study aims to document these functions over time to better understand their reliability and safety. Participants will be included soon after pacemaker implantation and followed for 48 months. Follow-up visits occur both on-site and remotely at 1 to 3 months, 6 months, 12 months, 24 months, and 48 months after inclusion. During these visits, the remote monitoring functions and the pacing systems performance will be measured, and safety will be continuously monitored throughout the study. Throughout the study, researchers will assess cardiac pacing thresholds, technical remote alerts, and the usability of the pacemaker and remote monitoring systems. Evaluations include Right Atrial and Right Ventricular pacing thresholds at multiple timepoints up to 48 months. Participants will undergo scheduled check-ins involving measurements, monitoring, and safety assessments, with the total study duration lasting four years after enrollment.

Atrial fibrillation AF is a common irregular heart rhythm that contributes to heart failure HF. Researchers are evaluating whether catheter ablation combined with optimal medical therapy can reduce hospitalizations due to heart failure and death compared to medical therapy alone. This international, randomized trial focuses on patients with HF and reduced heart function who have paroxysmal or persistent AF, aiming to clarify if ablation improves survival and quality of life beyond current treatments. Participants will be randomly assigned to either optimal medical therapy following European Society of Cardiology guidelines or to catheter ablation plus optimal medical therapy. The ablation procedure involves pulmonary vein isolation using techniques such as cryoballoon, radiofrequency, or pulsed field ablation, chosen by the treating physician. Additional ablation lesions may be applied as needed. This open-label multicenter trial plans to recruit 1200 patients and is nearly three times larger than previous studies in this area. During the study, participants will be monitored for a minimum of two years, with follow-up extending up to 5.5 years. The main outcome measured is the time to first all-cause death or urgent cardiovascular hospitalization. Secondary outcomes include repeated hospitalizations, quality of life assessed at six and twelve months, and cardiovascular death rates. Researchers will collect electro-anatomical voltage maps during ablation for further analysis, while patients will be regularly assessed for heart function, symptoms, and quality of life through clinical visits and questionnaires.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are evaluating the safety and effectiveness of the Shockwave Reducer device in patients with refractory angina pectoris who have persistent symptoms despite receiving the best medical therapy. This study includes a randomized, double-blinded, sham-controlled trial as well as a non-randomized registry for specific patient groups, such as those with right coronary artery ischemia or those unable to complete exercise tests. The trial aims to compare outcomes between patients receiving the device implant and those undergoing a sham procedure, focusing on those unsuitable for standard revascularization procedures. Participants in the randomized trial will be assigned to either receive the Shockwave Reducer implant or a sham implantation procedure without the device. Patients in the single-arm registry will receive the Shockwave Reducer device without randomization. The study involves detailed assessments including coronary angiography and functional tests to confirm eligibility. The treatment period and follow-up extend through six months to evaluate both safety and effectiveness outcomes. During the study, participants will undergo multiple evaluations including stress tests, imaging, and clinical assessments to monitor angina symptoms and cardiac function. Researchers will track key outcomes such as angina severity scores and safety endpoints at six months. Participants are expected to comply with follow-up visits and stable medication regimens, and the study includes careful monitoring to ensure adherence and collect comprehensive data on the devices impact on refractory angina symptoms.

Researchers are evaluating the Shockwave Intravascular Lithotripsy IVL System with the Shockwave Javelin Coronary IVL Catheter to treat calcified, narrowed coronary artery lesions before stenting. This prospective, multicenter, single-arm investigational device exemption study aims to assess the safety and performance of this device in patients with moderate to severely calcified coronary artery disease, including those with stable angina or after stabilization from acute coronary syndrome. The study uses the Shockwave Javelin Coronary IVL Catheter, designed to deliver intravascular lithotripsy to modify calcium in tight, difficult-to-cross lesions. This treatment aims to increase vessel compliance, allowing better device crossing and additional therapies as needed. Up to 158 subjects will be enrolled initially, followed by an extended cohort of up to 250 additional participants, all undergoing non-emergent percutaneous coronary intervention using the device. Participants will be monitored with assessments including freedom from major cardiac events within 30 days and technical success of the procedure during the intervention. The study involves screening, treatment with the investigational device, and follow-up visits to evaluate safety and effectiveness. Researchers will collect clinical data including biomarkers, heart function measurements, and angiographic imaging to assess outcomes throughout 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.