Ashington

Researchers are evaluating the efficacy and safety of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international study is a randomized, double-blind, placebo-controlled trial designed to assess how finerenone affects morbidity and mortality in these patients. Participants are randomly assigned to receive either oral finerenone or a matching placebo. The study is event-driven and ongoing for up to about 30 months, focusing on heart failure events and cardiovascular deaths. The trial includes careful monitoring of adverse events and treatment discontinuation due to side effects. During the study, participants will be closely monitored for heart failure events, cardiovascular deaths, and changes in symptoms using the Kansas City Cardiomyopathy Questionnaire. Regular assessments will track serious adverse events and safety. The total duration of participation may last up to approximately 30 months, with ongoing follow-up to understand long-term effects of the treatment.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This phase 3 global trial aims to see if this drug can reduce serious heart failure events like hospitalizations, urgent visits, and cardiovascular deaths, while improving heart failure symptoms. The study is event-driven and includes a double-blind period followed by an open-label extension. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial consists of two parts, with Part 1 ending when about 850 primary endpoint events have occurred. The study includes a double-blind treatment period and an open-label extension phase where all participants can receive the drug. During the trial, participants will undergo regular assessments including measurements of heart failure events, cardiovascular deaths, and symptom changes using the Kansas City Cardiomyopathy Questionnaire. Other evaluations include blood pressure, body measurements, kidney function, cholesterol, and blood markers related to heart failure and diabetes. The primary outcome is the time to the first cardiovascular death or heart failure event, measured over up to approximately 35 months. Safety and drug levels will also be monitored throughout the study.

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.

Researchers are evaluating the use of Implantable Cardioverter-Defibrillators ICDs in patients diagnosed with heart failure due to Non-Ischemic Cardiomyopathy NICM, a condition where the heart is weakened but not from blocked arteries. The trial aims to compare the overall survival rates of patients who receive an ICD versus those who do not over a period of 36 months and up to 10 years. This research addresses conflicting evidence about the benefits of ICDs and seeks to improve treatment guidelines for this patient group. Participants will be randomly assigned to one of two groups one group will receive an ICD or a Cardiac Resynchronisation Therapy Defibrillator CRTD, which are devices implanted under the skin to detect and treat dangerous heart rhythms, and the other group will not receive an ICD but may have an Implantable Loop Recorder or a Cardiac Resynchronisation Therapy Pacemaker CRTP. Both groups will continue to receive usual medical care. The study will monitor these groups to see if having an ICD reduces the risk of death. Throughout the study, participants will be followed for up to 10 years, with primary outcomes focused on the percentage of patients alive after 3 years. Researchers will also assess heart-related events, hospitalisations, quality of life using questionnaires, and device-related procedures. Regular monitoring will include clinical evaluations and collection of health data to understand the long-term effects and safety of ICD use in NICM patients.

Aortic stenosis AS affects many older adults, especially those over 65 years old, with increasing numbers due to an aging population. This condition often progresses silently until serious symptoms appear, requiring valve replacement surgery AVR or transcatheter aortic valve implantation TAVI. This research aims to compare early valve replacement to regular monitoring in patients with severe AS who have no symptoms, to understand which approach leads to better health outcomes and cost-effectiveness. The study is a large, open, randomized controlled trial conducted in multiple countries, including the UK, Australia, and New Zealand. Participants with severe asymptomatic AS will be randomly assigned to receive either early valve replacement surgery or ongoing regular monitoring without immediate surgery. Those in the surgery group will be placed on a waiting list aiming for surgery within three months and may undergo additional routine tests like coronary angiography. The monitoring group will continue with standard care and regular check-ups. Participants will be followed for at least three years to track outcomes such as cardiovascular death and hospitalizations for heart failure, along with quality of life and health economics measurements. The study includes regular assessments, questionnaires, and record linkages up to five years. Researchers will analyze outcomes based on the group participants were assigned to, regardless of actual treatment received, to provide clear information on the benefits and risks of early surgery versus expectant management.