Ashington

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are evaluating the safety and performance of the ConvaVAC13 Ag Negative Pressure Wound Therapy System in treating chronic wounds, specifically focusing on Venous Leg Ulcers VLUs. Chronic wounds are those that heal slowly or not at all, causing pain and affecting daily life. VLUs are the most common chronic leg wounds, affecting about 1 in 100 people, and current treatments include wound cleaning, special dressings, compression therapy, and antimicrobial creams or dressings. This study aims to see if the ConvaVAC13 Ag system can improve healing outcomes for VLUs effectively and safely. The ConvaVAC13 Ag system is a device that uses negative pressure wound therapy NPWT combined with silver ions, which have antimicrobial properties. NPWT involves applying a sealed dressing connected to a vacuum pump that removes excess fluid, promotes tissue growth, and reduces bacteria in the wound. The study involves participants receiving treatment with this device on their VLUs. The system aims to support wound healing by removing harmful biofilms and promoting tissue repair. Participants will be involved in the study for at least 14 days, during which the main measurement is the percentage reduction in wound size at day 14. Researchers will monitor wound healing progress and safety throughout the treatment period. The study helps assess how well the device performs in managing VLUs, with evaluations of wound condition and patient outcomes. The total participation time may vary depending on individual wound response and healing progress.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Researchers are conducting the ARC Study, a national observational cohort study in the United Kingdom to evaluate patient-reported and clinical outcomes after hip and knee replacement surgeries. The study aims to understand the results following these surgeries, identify risk factors for adverse outcomes, and find opportunities for future research and interventions. It also serves as a resource to support future clinical trials by providing comparison data from participants who have undergone primary hip or knee replacements. Participants in this study undergo elective primary hip or knee replacement surgery, including total hip replacement, total knee replacement, or unicompartmental knee replacement. All surgeries and postoperative rehabilitation follow standard hospital care and surgeon preferences. This study does not assign treatments but observes outcomes after usual care. Participants are recruited through surgical teams and advertising, then consent and enter data entirely online. During the study, participants provide baseline information about demographics, lifestyle, health status, and patient-reported outcome measures through an online portal. Follow-up questionnaires are completed online for up to two years after surgery to track outcomes such as quality of life, pain, activity, return to work, and complications. The main measure is the EQ-5D-5L health-related quality of life score at two years. This long-term observational study helps researchers learn about recovery and complications following hip and knee replacements.

This research aims to compare the fluid absorption performance of two commonly used CE-marked superabsorbent dressings in people with venous leg ulcers VLUs. The study focuses on how well each dressing manages wound exudate, prevents skin maceration, and avoids leakage, which are important factors for promoting wound healing during routine care. Participants will be randomly assigned to use either the Cutimed Sorbion product range or the Zetuvit RespoSorb product range for managing exudate from their VLUs. Both product groups include various dressing types designed to absorb wound fluid. The study will last up to 30 days, during which participants will receive regular dressing changes and wound care. Throughout the study, participants will attend scheduled visits for assessments including the frequency of dressing changes, skin condition around the wound, wound tissue changes, pain levels, and patient and healthcare provider satisfaction. Quality of life will be measured using a specific questionnaire at the start and end of the study. Safety and wound healing progress will be closely monitored over the 30-day period.

This research is investigating the use of Implantable Cardioverter-Defibrillators ICDs in adults diagnosed with heart failure caused by Non-Ischemic Cardiomyopathy NICM, a condition where heart failure is not due to blocked arteries. The study aims to compare the all-cause mortality rates between patients who receive an ICD and those who do not, over a period of 36 months and extending up to 10 years. This trial addresses ongoing questions about whether ICDs benefit patients with NICM, especially given recent findings that many patients with ICDs do not experience serious heart rhythm problems. Participants are randomly assigned to one of two groups one group will have an ICD or Cardiac Resynchronisation Therapy Defibrillator CRTD implanted, which are devices designed to detect and correct dangerous heart rhythms. The other group will not receive an ICD but may have an Implantable Loop Recorder or a Cardiac Resynchronisation Therapy Pacemaker CRTP, alongside their usual medical care. The study will monitor both groups to determine if ICD implantation improves survival compared to no ICD over the study period. Throughout the trial, participants will be regularly evaluated with health assessments including quality of life questionnaires and monitoring of heart-related events such as hospitalizations and arrhythmias. Researchers will track outcomes like survival percentage, heart rhythm events, and device-related procedures over 3 years, with some outcomes also measured at 5 and 10 years. The study includes close observation of safety and effectiveness, with participants followed to understand long-term impacts of ICD therapy in this patient group.

Aortic stenosis AS affects many older adults, with a rising number of people over 65 and 75 years old experiencing moderate to severe disease. This study aims to compare the benefits of early aortic valve replacement AVR versus expectant management in patients with severe asymptomatic AS. It addresses a significant gap, as no randomized controlled trials have yet compared these approaches to determine which leads to better outcomes and cost-effectiveness. Participants will be randomly assigned to either early AVR, where surgery or transcatheter AVR TAVI is planned within six months, or to expectant management, involving regular monitoring according to standard hospital practice. The study will be conducted across multiple centers in the UK, Australia, and New Zealand, with an internal pilot phase to confirm recruitment feasibility. Those in the AVR group may undergo additional tests such as coronary angiography, with further treatment decisions made by their care team. During the study, participants will be followed for a median of 5.5 years, with assessments including cardiovascular events, hospitalizations, quality of life questionnaires, and health economics evaluations. Researchers will measure a combined outcome of cardiovascular death, heart failure hospitalization, and stroke, along with other health and disability measures. The study will use intention-to-treat analysis, ensuring participants are evaluated in their assigned groups regardless of treatment received.