Bad Bevensen

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

The Abbott Vascular Medical Device Registry (AV-MDR) is a prospective, non-randomized, open-label, multi-center registry designed to collect and evaluate clinical data on various Abbott vascular devices. The study focuses on confirming the safety and performance of these devices throughout their expected lifetime, monitoring risks, detecting new issues based on actual evidence, and ensuring that the benefit-risk balance remains favorable. It also aims to identify any possible misuse or off-label use to verify appropriate device use in patients with conditions such as acute myocardial infarction, coronary artery lesions, restenoses, and embolisms. Participants receive one or more Abbott vascular devices including coronary and peripheral stents, pacing catheters, vascular plugs, measurement and imaging devices such as fractional flow reserve (FFR) and optical coherence tomography (OCT), peripheral and coronary dilatation catheters, coronary and peripheral guidewires, vessel closure and compression devices, or vascular access introducers. The devices are used during planned or completed vascular procedures, with treatment and device types depending on the participant's medical needs and the study scope. Throughout the study, participants are monitored during the vascular procedure and followed up at multiple time points including during the procedure, at 30 days, and at 12 months. Researchers assess outcomes such as death, myocardial infarction, target lesion revascularization, amputations, device success, complications, and imaging quality. The study involves collecting data on device performance and safety events, ensuring adherence to follow-up schedules, and aims to provide comprehensive information on the long-term use and risks associated with Abbott vascular devices.

Researchers are studying how gastrointestinal (GI) symptoms develop in patients with anorexia nervosa (AN) and bulimia nervosa (BN) during several weeks of inpatient weight rehabilitation. This observational study focuses on how different nutritional strategies—flexitarian, vegetarian, or vegan diets—affect changes in GI symptoms. It also looks at how weight gain and various clinical, psychological, and demographic factors influence the course of these symptoms. The study is conducted at the Eating Disorder Center of the Klinik Lüneburger Heide in Germany and aims to enroll about 150 patients with AN and 35-40 with BN. Participants receive treatment involving nutritional rehabilitation while following their predominant diet type. During the multi-week inpatient stay, patients complete weekly questionnaires about their GI symptoms as part of routine care. The study collects additional data from standard clinical assessments, including measurements of body weight, body composition, and psychological evaluations. The primary focus is on the change in GI symptom severity from admission to discharge, analyzed in relation to diet and weight changes. Secondary analyses will examine symptom progression over time, differences between AN and BN groups, and factors predicting symptom improvement. Throughout the study, participants provide weekly information on their GI symptoms and undergo regular clinical assessments. Researchers track changes using the GSRS score at two key points: within the first three days after admission and during the final three days before discharge. The study also gathers data on psychological status, symptom changes, weight trends, and treatment duration. The goal is to use these findings to develop evidence-based dietary recommendations for people with eating disorders who experience GI symptoms during nutritional rehabilitation.

Researchers are studying the drug levosimendan taken orally to evaluate its safety and effectiveness compared to a placebo in adults with pulmonary hypertension associated with heart failure with preserved left ventricular ejection fraction (PH-HFpEF). The main goal is to see if levosimendan improves exercise ability, measured by the change in the distance walked in six minutes. This is a Phase 3 clinical trial involving approximately 540 participants. Participants will be randomly assigned in a 2:1 ratio to receive either oral levosimendan or a matching placebo. After the initial study period, those who qualify may join an open-label extension lasting 52 weeks to continue receiving the study drug. The study carefully monitors the participants' health and responses during these phases. Throughout the trial, participants will undergo various assessments including right heart catheterization, echocardiograms, and a six-minute walk test to measure exercise capacity. Heart rhythm will be monitored using a 48-hour ambulatory cardiac monitor during screening. Safety and effectiveness are tracked over at least 26 weeks, with the primary measurement being the six-minute walk distance. Participants may be followed for up to a year if they enter the extension phase.

The VISTA Nova Study investigates the safety, performance, and long-term durability of the Navitor valve in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). This global post-market study aims to assess these outcomes in a real-world clinical setting, focusing on patients eligible for the Navitor TAVI procedure based on current approved indications. Participants will receive the Navitor Transcatheter Aortic Valve, delivered using the FlexNav Delivery System and the Navitor Loading System. The study follows patients who undergo the TAVR procedure with this device, monitoring their outcomes to evaluate device performance and safety. During the study, participants will be observed for key outcomes including all-cause mortality and the occurrence of moderate or greater paravalvular leak at 30 days after the TAVI procedure. Patients are expected to return for all required post-procedure follow-up visits to monitor these outcomes, with safety and performance data collected throughout the study duration.