Basildon

Researchers are investigating whether encapsulated faecal microbiota transplantation (FMT) can help reduce infections and mortality in adults with alcohol-related or metabolic dysfunction-associated steatotic liver disease (MASLD) cirrhosis. Cirrhosis, a severe scarring of the liver, is a growing health crisis, leading to high rates of early death, with infections being a major complication. Previous trials showed that FMT delivered endoscopically is safe, and this study aims to test a capsule form of FMT to improve patient outcomes without the need for invasive procedures. Participants will be randomly assigned to receive either encapsulated FMT or placebo capsules that look identical. They will take five capsules every three months for up to 21 months or until they develop an infection requiring hospital admission. This double-blind trial will follow participants for up to 24 months to compare infection rates and time to hospitalization between the two groups. The study will also explore if FMT improves liver function, immune response, and reduces harmful bacteria linked to cirrhosis complications. During the study, participants will be closely monitored for infections and other cirrhosis-related complications through hospital visits and assessments. Researchers will measure the time until the first infection or decompensation leading to emergency or hospital admission. Laboratory tests will evaluate immune system changes and the presence of antibiotic-resistant bacteria. The trial will last up to two years, aiming to provide insights into new, antibiotic-free treatments for cirrhosis and influence future care and policy.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

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 use of Bioimpedance Analysis (BIA) to help manage fluid levels in patients hospitalized with worsening heart failure symptoms. This study focuses on whether BIA-guided fluid management can reduce the need for additional treatment, such as diuretics, or rehospitalization within 90 days after discharge. It compares BIA-guided treatment to standard care in patients admitted with decompensated heart failure, aiming to improve fluid management and patient outcomes. Participants are randomly assigned to one of two groups. The BIA-Guided Treatment Group receives BIA measurements within 24 hours of admission and throughout their hospital stay to guide diuretic therapy and fluid management. The Standard Care Group also has BIA measurements taken at admission and discharge, but these results are not shared with the clinical team, who manage fluid levels using usual care methods. All patients receive follow-up care 2-4 weeks after discharge, including health checks, blood tests, and a questionnaire about quality of life related to heart failure. During the study, researchers collect BIA data, clinical assessments, blood tests including NTproBNP, and patient-reported outcomes using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). The primary outcome measured is the rate of heart failure events, such as rehospitalization or increased diuretic use, within 90 days post-discharge. Safety and longer-term outcomes will be monitored, with data analyzed after all participants have been followed for at least 12 months.

This research aims to understand the genetic factors that contribute to the risk of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR). GCA is a serious inflammatory disease affecting blood vessels, mainly in people over 50, which can cause severe complications like vision loss or stroke if untreated. PMR causes pain and stiffness in the limbs with signs of inflammation. The study involves both patients recently suspected of having GCA and those with confirmed diagnoses from the past. It seeks to provide new insights into disease causes and improve diagnosis and treatment approaches. Participants are observed in a multi-center study collecting clinical and genetic data. The study includes both prospective patients with suspected GCA and retrospective patients with confirmed GCA or PMR diagnoses. Some retrospective participants receiving tocilizumab for recurring or difficult-to-treat GCA are also included in a safety monitoring registry. Data collected include clinical features, imaging, tissue and blood samples, and advanced genetic testing. The study also follows patients over time to assess disease impact, quality of life, and long-term outcomes. During the study, participants provide medical information, biological samples, and complete questionnaires about their symptoms and quality of life. Researchers monitor disease activity and treatment effects, especially among those starting certain immune-modifying drugs. The main measurements focus on genetic susceptibility at the study start, with ongoing evaluation of diagnosis, prognosis, and disease progression. The study is designed to improve understanding and management of GCA and PMR over time.

Researchers are evaluating the safety and performance of remote monitoring functions in pacemakers, specifically the ALIZEA, BOREA, and CELEA devices. These remote features include the Right Atrial Autothreshold (RAAT), Right Ventricular Autothreshold (RVAT), and technical remote alerts. The study focuses on patients with bradycardia who have recently received one of these pacemakers as part of their cardiac care. Participants will undergo implantation or device upgrade with an ALIZEA, BOREA, or CELEA dual chamber pacemaker. The study involves activating remote monitoring functions on these devices to track cardiac pacing performance and system safety. Follow-up visits will occur at 1 to 3 months, 6 months, 12 months, 24 months, and 48 months after inclusion, during which device function and remote monitoring data will be assessed. During each follow-up, either in person or remotely, researchers will measure the pacemaker's performance, including pacing thresholds and remote alerts. Safety will be closely monitored throughout the entire 48-month study period. The main outcomes include changes in right atrial and right ventricular pacing thresholds and documentation of technical remote alerts between 1 and 3 months after device implantation.

Atrial fibrillation (AF) is a common heart rhythm disorder that causes irregular heartbeats and worsens heart failure (HF). This research aims to compare catheter ablation combined with optimal medical therapy against optimal medical therapy alone to see if ablation reduces unplanned heart failure hospitalizations, death rates, and improves quality of life. The trial addresses the lack of conclusive evidence in general heart failure populations, building on smaller previous studies and involving a larger, more representative group of patients. Participants in the catheter ablation group will undergo Pulmonary Vein Isolation (PVI) using techniques like Cryoballoon, Radiofrequency, or pulsed field ablation, with the exact method chosen by the treating doctor. Additional ablation may be performed as needed. The other group will receive optimal medical therapy following current heart failure guidelines. This is a randomized, open-label, multicenter trial involving 1200 patients with heart failure and reduced ejection fraction, with AF that is either paroxysmal or persistent. During the study, participants will be monitored for at least 2 years to track time to first all-cause death or urgent cardiovascular hospitalization. Researchers will collect data including electro-anatomical voltage maps during ablation procedures and assess quality of life improvements. Patients must be able to comply with study requirements for at least 12 months. Safety and outcomes related to heart failure and atrial fibrillation will be carefully followed throughout the trial.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating the effects of three different treatments on major adverse kidney events (MAKE) in adults who are unconscious after being resuscitated from out-of-hospital cardiac arrest. This sub-study is part of the larger STEPCARE trial and involves 3,500 participants. The study focuses on kidney-related outcomes, including death within 30 days, need for kidney replacement therapy, and kidney function changes measured by creatinine levels at hospital discharge. The main trial randomly assigns patients to one of three treatments: continuous deep sedation for 36 hours versus minimal sedation; fever control using a feedback-controlled device if body temperature rises above 37.7°C versus fever control without a device; and two blood pressure targets with mean arterial pressure (MAP) set to either ≥65 mmHg or ≥85 mmHg maintained by vasopressors for 36 hours. The feedback-controlled temperature device is set to maintain temperature at 37.5°C when used. Participants will be closely monitored during their hospital stay with data collected prospectively according to the main trial protocol. Researchers will assess major adverse kidney events within 30 days and examine creatinine changes during the hospital stay and within 72 hours after resuscitation. The study aims to understand how these treatments affect kidney outcomes after cardiac arrest, with analyses following a predefined statistical plan.

Researchers are evaluating the safety and effectiveness of the Shockwave Reducer, an implantable device, for treating patients with refractory angina pectoris who continue to have symptoms despite receiving the best possible medical therapy. The study includes patients with evidence of reversible myocardial ischemia in the left coronary artery distribution who are not suitable for revascularization. Additionally, a non-randomized single-arm registry will assess the device in patients with ischemia in the right coronary artery, those without obstructive coronary disease but abnormal coronary flow reserve, and those unable to complete exercise testing due to limb amputation or mobility issues requiring walking aids. The study is a multicenter, randomized, double-blinded, sham-controlled trial with three groups. One group receives the Shockwave Reducer implant, another undergoes a sham implantation procedure without device placement, and a third group participates in a non-randomized registry receiving the device. The device is implanted in the coronary sinus, and patients continue their stable anti-anginal medication regimen. The study monitors outcomes over six months after implantation. Participants will be evaluated through various tests including stress echocardiography, nuclear imaging, PET, MRI, CT perfusion, and physiological assessments to confirm reversible ischemia. They will also undergo exercise tolerance tests, echocardiography to assess heart function, and angiography. Researchers will measure effectiveness and safety endpoints at six months. Follow-up visits and tests will ensure adherence and monitor for any adverse events. Total participation includes screening, treatment, and follow-up over at least six months.