Redhill

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.

Severe diabetic macular oedema (DMO) is a condition where fluid builds up in the macula, the central part of the retina responsible for detailed vision, leading to sight loss. This trial studies people over 18 years old with type 1 or type 2 diabetes who have severe DMO, defined by a thickened macula (400 microns or more). Researchers are comparing the current standard treatment of anti-VEGF eye injections alone to a new approach where patients start with anti-VEGF injections and switch to subthreshold micropulse laser (SML) treatment once the macula thickness decreases below 400 microns. Participants will be randomly assigned to receive either ongoing anti-VEGF injections or to switch to SML treatment after initial anti-VEGF therapy. Anti-VEGFs such as ranibizumab, aflibercept, faricimab, and brolucizumab are given as monthly injections at first, then every 1-3 months. The SML procedure, which does not damage the macula, will be applied based on the trial guidelines once the macula is less than 400 microns thick. This study aims to see if the combined treatment is as effective and more cost-efficient than anti-VEGF injections alone. Participants will attend regular clinic visits for eye exams including optical coherence tomography (OCT) scans to measure macula thickness and assessments of visual acuity over 104 weeks after randomization. Researchers will monitor best-corrected visual acuity, side effects, participant experience, and cost-effectiveness. The trial includes follow-up for two years with safety monitoring and evaluation of how this approach might be adopted in routine care. The study is conducted at multiple hospital eye services across the UK.

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 investigating heart failure patients with Non-Ischemic Cardiomyopathy (NICM), a condition where heart failure is not caused by blocked arteries. The study aims to compare survival rates between those who receive an Implantable Cardioverter-Defibrillator (ICD) and those who do not over a period of 36 months, with follow-up extending up to 10 years. This research could influence future international guidelines for managing this type of heart failure. Participants will be randomly assigned to one of two groups: one group will receive an ICD or a Cardiac Resynchronisation Therapy Defibrillator (CRTD), devices implanted under the skin that monitor and correct dangerous heart rhythms. The other group will not receive these devices. The device implantation is done under local anesthesia and includes leads fixed inside the heart chambers. Both groups will be monitored to see if the ICD reduces the risk of death. During the study, participants will undergo assessments including cardiovascular magnetic resonance imaging to evaluate heart scarring. Researchers will monitor survival rates and complications related to device implantation, such as bleeding, infections, or inappropriate shocks. The main outcome measured is the percentage of patients alive at 3 years. Safety and long-term effects will be followed to understand the balance of benefits and risks over time.

Researchers are evaluating the real-world effectiveness of nemolizumab for treating moderate-to-severe atopic dermatitis (AD) in adolescents and adults. This study is a prospective, multicenter, non-interventional trial that aims to measure treatment outcomes through physician assessments and patient-reported outcomes over approximately 12 months. The goal is to understand how nemolizumab works in routine clinical practice, focusing on physician evaluations and patient experiences at Month 6. Treatment with nemolizumab is determined solely by the participant's physician before joining the study, with no extra visits, procedures, or lab tests beyond standard care. The study does not define a specific visit schedule; instead, visits follow routine medical practice to collect data systematically. A sub-study in Germany and the UK will have participants complete daily questionnaires on itch severity, sleep disturbance, and pain from Day -1 to Day 14 remotely, without requiring clinic visits. Participants will be involved in routine clinical visits where physician assessments and patient-reported outcome measures will be gathered. Key outcomes measured include the Investigator Global Assessment (IGA) and the Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6. The study observes participant responses and safety under normal care conditions, with data collection lasting about a year to evaluate nemolizumab's effectiveness in everyday treatment settings.

This research focuses on participants with Hidradenitis Suppurativa (HS) who have previously taken part in specific Incyte-sponsored clinical trials of povorcitinib. The study is a Phase 3b rollover trial designed to continue monitoring these individuals to gather further information on the treatment. It aims to evaluate the safety of povorcitinib over an extended period, including the proportion of participants experiencing treatment-emergent adverse events for up to about three years. Participants will continue taking the study drug povorcitinib orally as specified by the study protocol. This rollover study includes individuals who completed the treatment period in the parent studies without safety or tolerability issues and who showed clinical benefit from povorcitinib. During this study, participants will follow the protocol-defined dosing and procedures while avoiding pregnancy or fathering children as required. Throughout the study, participants will attend scheduled visits and assessments to monitor their health and treatment effects. Researchers will track adverse events and adherence to the treatment plan. The study involves ongoing evaluation for up to approximately three years to ensure safety and collect important long-term data on povorcitinib use in this group of patients with HS.

Researchers are studying the long-term safety, performance, and clinical benefits of pacing the left bundle branch area using the INGEVITY+ pacemaker lead in patients with bradycardia who need a pacemaker. This observational post-market follow-up study focuses on patients with conditions such as bradycardia, atrioventricular block, sinus node dysfunction, and bundle-branch block. The goal is to better understand how this specialized pacing method works over time in real-world patients. The investigational device is a bipolar, steroid-releasing pacemaker lead designed for chronic stimulation and sensing, implanted specifically in the left bundle branch area. The lead is connected to a Boston Scientific single- or dual-chamber pacemaker. Implantation is done using a compatible CE-marked catheter. The study follows patients from the implantation procedure forward, assessing device success and ongoing heart function. Participants will undergo scheduled clinic visits and testing as defined by the study protocol to monitor the device's performance and patient health. Researchers will evaluate outcomes such as the success rate of the implant procedure and the maintenance of ventricular synchrony over a three-year follow-up period. Safety, clinical benefits, and device performance will be carefully tracked throughout the study duration.

Researchers are conducting a prospective observational study to evaluate the health of multiple organs using multiparametric abdominal magnetic resonance imaging (MRI) in adults with type 2 diabetes who have no history of cardiovascular disease. The study aims to determine if MRI metrics can predict future clinical events over five years, focusing on cardiovascular outcomes such as heart attacks, strokes, and hospitalizations. Participants will not receive any new treatments as part of this study; instead, they will undergo standard care and two study visits. The first visit involves physical measurements and collection of blood and urine samples to assess diabetes status and biomarkers. The second visit includes a multi-organ MRI scan. Both visits occur within 28 days of the initial screening, which includes medical review and informed consent. During the five-year participation, researchers will collect MRI data, clinical outcomes, blood and urine samples, and access medical records from NHS England and local healthcare providers. Follow-up data on hospital admissions and mortality will be gathered at 1, 3, and 5 years after the baseline assessment. The primary outcome is the incidence of major cardiovascular events over three years based on baseline MRI findings.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.