Slough

Researchers are evaluating two different methods of pacing the heart in patients with slow heart rates (bradycardia). This multi-center randomized controlled trial, called PROTECT-HF, aims to compare the standard right ventricular pacing approach with a newer physiological pacing technique, which includes His bundle and left bundle area pacing. The study will enroll 2600 patients to assess differences in outcomes related to heart function and survival. Participants will be randomly assigned to receive either right ventricular pacing or physiological pacing through pacemaker implantation. The physiological pacing method may involve His bundle pacing or left bundle pacing, with biventricular pacing used if these are not possible. Both treatments will be performed at participating centers, with patients and outcome assessors blinded to the treatment allocation. A subgroup of 500 patients will also take part in an optional echocardiographic sub-study to observe heart changes over 24 months. During the study, participants will be monitored from the time of consent for up to 78 months. Evaluations will occur at the start and every six months afterward to track mortality and heart failure-related health events. Researchers will gather data on heart function, treatment effects, and safety. The main analysis will consider all patients as originally assigned, and additional analysis will assess those who received the assigned treatment.

Researchers are conducting a phase III, randomized, open-label, international trial to compare ruxolitinib with the best available therapy for patients with high-risk polycythemia vera (PV). The best available therapy includes either interferon alpha or hydroxycarbamide, selected by the investigator before randomization. This study aims to evaluate which treatment better prevents major complications like thrombosis, hemorrhage, or progression to more severe blood disorders within approximately three years. Participants will be randomly assigned to receive either ruxolitinib at a dose of 10 mg twice daily or best available therapy consisting of interferon alpha or hydroxycarbamide, administered through standard hospital methods. There will be no crossover between treatment arms during the trial. Interferon formulations, including pegylated-interferon, may be used at the investigator's discretion. During the study, participants will be monitored for event-free survival, defined as the time until the first major thrombosis, hemorrhage, death, or disease transformation. Assessments will include regular clinical evaluations and laboratory tests over the approximately three-year trial period. The trial emphasizes safety and effectiveness by closely observing patient outcomes and treatment tolerability throughout the study.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Chronic obstructive pulmonary disease (COPD) is a common lung condition affecting about 10% of adults worldwide, with a prevalence of 4.5% in those aged 40 years and older in the UK. Exacerbations, or sudden worsening episodes often triggered by infections, can lead to hospital admissions and carry risks of increased illness and death. This trial focuses on the high-risk 90-day period after hospital discharge, during which patients have a 43% chance of readmission and 12% risk of mortality. The study aims to test whether a supported rescue pack management plan can reduce readmissions by 20%. This is a Phase 3, open-label, multicenter randomized controlled trial involving 1400 patients across 30 NHS trusts.