Croydon

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 evaluating the effectiveness and safety of ruxolitinib cream in children aged 6 to under 12 years with nonsegmental vitiligo, a condition causing skin depigmentation. This phase 3 study focuses on children who have vitiligo affecting specific body areas, including the face and other parts, with certain minimum involvement percentages required for enrollment. Participants will be randomly assigned to receive either ruxolitinib cream or a matching vehicle cream, both applied topically as a thin film twice daily to affected areas. The study is double-blinded, meaning neither the participants nor the researchers know who receives which cream. Treatment will continue with regular assessments to monitor progress and safety. During the study, children will have their vitiligo area measured using the Facial Vitiligo Area Scoring Index (F-VASI) to assess improvement, with the main goal being at least a 75% improvement by week 24. Participants must stop all other vitiligo treatments during the study and will be closely monitored for safety and adherence through scheduled visits and evaluations. The total body vitiligo area must be 10% or less for participation.

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 Heartfelt device, a new passive monitoring system designed to detect early signs of fluid build-up (oedema) in people 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. Heart failure often causes swelling and breathlessness due to fluid accumulation, and early detection is important to prevent worsening health and hospital admissions. The trial will involve 300 participants from at least 15 NHS hospitals and GP practices across the UK. Participants will be randomly assigned to two groups: one will receive standard NHS care, which includes regular weight checks, symptom monitoring, and educational materials; the other group will receive the same care plus the Heartfelt device installed in their home. The device takes daily images of the feet to track size changes and sends alerts to the clinical team if important changes are detected. The Heartfelt device also provides audio-visual alerts to patients, carers, and medical professionals in the device group. Participants will be followed for 12 months, during which their quality of life will be assessed using questionnaires at baseline, 3, 6, 9, and 12 months. Researchers will monitor heart failure events, healthcare use, device data availability, and response to alerts. The study will also evaluate how easy the device is to use and its cost-effectiveness. Patients will help shape the study to ensure its relevance and usefulness for future care.

Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy. However, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians simply replace it like-for-like. This trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy from the traditional RV pacing approach. In this crossover trial, participants will be upgraded to a physiological pacing strategy. After their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing). They will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods. Patients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire. The investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.

Researchers are investigating new treatments for patients with relapsed or refractory follicular lymphoma, aiming to find therapies that improve outcomes compared to current standard treatments. This Phase II trial, called REFRACT, compares experimental treatments with standard care selected by the patient's doctor, based on patient response to therapy after 24 weeks as measured by PET scans. The study will enroll 284 patients over five years and includes long-term follow-up for up to 10 years. Participants will be randomly assigned to receive either one of three sequential experimental treatments or investigator choice standard therapy (ICT). In the first round, patients have a 50% chance of receiving epcoritamab combined with lenalidomide. Epcoritamab is given as a weekly injection during the first two 28-day cycles and then once on day one of subsequent cycles up to 12 cycles. Lenalidomide is taken orally on days 1 to 21 of each cycle. The second and third rounds will test other experimental treatments, with patients more likely to receive the experimental therapy. Standard therapy options may include combinations such as RCHOP, RCVP, lenalidomide and rituximab, bendamustine and rituximab, or obinutuzumab and bendamustine. During the study, participants will undergo PET-CT scans to assess their disease and treatment response. Researchers will monitor safety and effectiveness through these scans and other evaluations. After completing treatment, patients will be followed up yearly to track long-term outcomes. The main outcome measured is the complete metabolic response at 24 weeks. Participants must meet specific health and disease criteria to join and will provide informed consent before participating.