Bernau Bei Berlin

Researchers are studying real-world patient characteristics, treatment patterns, and both short- and long-term outcomes in people with symptomatic obstructive hypertrophic cardiomyopathy HCM across the United States and Europe. The study focuses on patients receiving mavacamten, other treatments for obstructive HCM, or no treatment due to intolerance or prior treatment failure. The U.S. portion evaluates the safety of mavacamten in this setting, while the European part assesses both its effectiveness and safety. Participants receive treatments as part of standard care, either mavacamten or other medications such as beta-blockers, non-dihydropyridine calcium channel blockers, or disopyramide. Treatments are prescribed by physicians according to routine clinical management. The study observes outcomes over time without altering prescribed care. During the study, participants are monitored for changes in heart function, symptoms, and adverse events through clinical assessments including echocardiography and patient-reported questionnaires. Researchers evaluate heart failure events, heart function measures like left ventricular outflow tract gradient and ejection fraction, arrhythmias, hospitalizations, mortality, and quality of life scores. Data is collected at baseline and followed for up to five years to understand real-world treatment effects and safety.

This observational study aims to collect clinical information on the safety and performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO Aortic Arch Stent Graft System for treating aortic aneurysms. The main questions focus on early mortality, safety outcomes, device failure, and procedural and hospitalization details. Participants are treated according to standard care at their institutions. Participants receive treatment per their institutions standard of care using either the NEXUS Aortic Arch Stent Graft System or the custom-made NEXUS DUO Aortic Arch Stent Graft System. The study includes both prospective and retrospective data collection with two groups based on the device used. Follow-up information is collected for up to five years after treatment. During the study, researchers will gather data on mortality at 30 days and 12 months, major adverse events, device failure, and other safety outcomes. Participants will undergo regular follow-up visits to monitor these outcomes and collect hospitalization and procedural information. The study is designed to observe real-world use of these devices and understand their longer-term safety and performance.

Researchers are collecting data to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in repairing the mitral valve through a minimally invasive procedure called transcatheter mitral valve repair. The study focuses on patients with mitral regurgitation to understand how well these devices improve valve function, symptoms, and quality of life in real-world settings after market approval. Participants receive treatment using either the Edwards PASCAL System or the Edwards PASCAL Precision System for transcatheter mitral valve repair. This study is conducted in a postmarket clinical follow-up format, meaning the devices are already approved and are now being further studied to gather safety and effectiveness data over time. During the study, patients will be monitored for major adverse events within 30 days and assessed for changes in mitral regurgitation severity by echocardiography at discharge or 7 days after the procedure. Participants will also attend follow-up visits where functional status and quality of life will be evaluated. The study aims to collect comprehensive safety and effectiveness information over the course of participation, which begins after the mitral valve repair procedure and continues through scheduled follow-ups.

Researchers are evaluating the real-world use of nemolizumab for treating moderate-to-severe atopic dermatitis AD in adolescents and adults. This observational study aims to assess the treatments effectiveness through physician evaluations and patient-reported outcomes over six months, providing insight into how the medication performs in everyday clinical practice. Participants receiving nemolizumab as part of their routine care will be observed for about 12 months. Treatment decisions are made by the participants physician before joining the study, with no extra visits or tests beyond usual medical care. A sub-study in Germany and the UK involves daily remote reporting of symptoms such as peak and average itch, sleep disturbance, and pain for the first two weeks. During the study, participants will have regular medical visits as determined by their doctors, with data collected from routine assessments and patient questionnaires. Researchers will measure outcomes like the Investigator Global Assessment and Peak Pruritus Numerical Rating Scale at six months, along with other severity and symptom scores up to 12 months. No additional procedures outside standard care are required, allowing for natural monitoring of treatment effects and safety.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.