Croydon

Researchers are evaluating two different pacing methods for patients with slow heart rates, called bradycardia. This study compares the common right ventricular pacing approach with a newer physiological pacing method that includes His bundle and left bundle area pacing. The trial aims to better understand how these pacing techniques affect patient outcomes, including mortality and heart failure morbidity, in a large group of 2600 patients. Participants will receive a pacemaker implant and be randomly assigned to either right ventricular pacing or physiological pacing. The physiological pacing may involve His bundle pacing or left bundle pacing, but if these are not successful, biventricular pacing will be used. A subgroup of 500 participants will take part in an optional echocardiographic sub-study to assess heart function changes over a 24-month period. Throughout the study, patients will be assessed at baseline and every six months after randomization, with follow-up lasting up to 78 months. Researchers will monitor outcomes such as mortality, heart failure events, device-related safety issues, patient quality of life, symptoms, and pacemaker-derived data like arrhythmias and activity levels. The echocardiographic sub-study will measure specific heart function changes to understand pacing-induced cardiomyopathy. Participants involvement includes implantation, regular follow-up visits, questionnaires, and optional imaging assessments.

Researchers are studying the use of ruxolitinib cream in children aged 6 to under 12 years who have nonsegmental vitiligo. The study aims to evaluate how well and how safely the cream works for treating this condition, which causes loss of skin color. This is a Phase 3 clinical trial focused on treatment effects in this pediatric population. Participants are assigned to one of three groups receiving either ruxolitinib cream at 0.75% or 1.5%, or a matching vehicle placebo cream. Each cream is applied topically as a thin film twice daily to the affected skin areas as defined in the study protocol. The treatment period lasts up to 24 weeks, during which changes in skin pigmentation are monitored. Throughout the study, participants undergo regular assessments including evaluations of vitiligo improvement on the face and body using the Vitiligo Area Scoring Index and other scales. Safety is monitored by tracking adverse events and blood levels of the drug at multiple timepoints up to 52 weeks. Quality of life and psychosocial effects are also measured. The total study duration includes treatment and follow-up visits to assess long-term outcomes and safety.

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 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 pacing methods to improve symptoms and quality of life for patients with pacemakers. This trial focuses on patients who have a traditional right ventricular RV pacemaker and impaired heart function, testing whether switching to a modern physiological pacing strategy can provide better outcomes. The study is a crossover trial comparing physiological pacing methods to continued RV pacing in patients with pacing-induced cardiomyopathy and heart failure. Participants will first undergo an upgrade procedure to physiological pacing, which may involve His bundle pacing, left bundle pacing, or biventricular pacing if the first two approaches are not possible. After the procedure, there is a one-month recovery period with continued RV pacing. Then participants experience two one-month blinded periods alternating between physiological pacing and RV pacing, followed by two six-month blinded crossover periods. The RV pacing is performed at apical or septal lead locations as per usual practice. During the study, participants will record symptoms monthly using a mobile app or computer. At the end of each period, heart function will be assessed along with a walking test and quality-of-life questionnaires, including the SF-36 survey. Other measurements include left ventricular function, atrial fibrillation monitoring, BNP blood tests, and patient preference surveys. Safety monitoring continues throughout the study, which lasts about fourteen months from baseline to final follow-up.

Researchers are investigating new treatments for patients with relapsed or refractory follicular lymphoma, aiming to find better options than the current standard therapies. This Phase II trial compares experimental therapies to standard treatments chosen by doctors before the trial. The study focuses on how patients respond to treatment, measured by PET scans after 24 weeks, to identify therapies that may improve outcomes. Patients will be randomly assigned to receive either an experimental treatment or one of five standard therapy options, such as RCHOP or bendamustine with rituximab. In the first treatment round, patients may receive epcoritamab by weekly injection combined with oral lenalidomide in 28-day cycles, up to 12 cycles. Subsequent rounds will test other new treatments, with patients more likely to receive the experimental option. The trial plans to enroll 284 patients and follow them for up to 10 years. Participants will undergo assessments including PET-CT scans, blood tests, and quality of life questionnaires before and during treatment. Researchers will track treatment responses, survival, adverse effects, and quality of life over the study period. After treatment, patients will be followed yearly to monitor long-term outcomes and any new treatments needed, with total participation lasting up to a decade.