Bad Bevensen

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are collecting and evaluating clinical data on various Abbott vascular medical devices used for conditions such as acute myocardial infarction, coronary artery lesions, restenoses, venous embolism, and arterial embolism. This prospective, non-randomized, open-label, multi-center registry aims to confirm the safety and performance of these devices over their expected lifetime. The study also focuses on monitoring identified risks, detecting new risks based on actual evidence, ensuring the benefit-risk balance remains acceptable, and identifying any misuse or off-label use of the devices. Participants are grouped based on the type of device used in their vascular procedure. These devices include coronary and peripheral stents, pacing catheters, vascular plugs, measurement and imaging tools FFR and OCT, peripheral and coronary dilatation catheters, coronary and peripheral guidewires, vessel closurecompression devices, and vascular access introducers. Each participant receives the device relevant to their treatment as part of their procedure. During the study, researchers track participants from the start of their procedure, defined as the time a guidewire first enters the vasculature, until vessel closure following the procedure. They monitor outcomes such as death, myocardial infarction, target lesion revascularization, device-related complications, and procedural success at various points including during the procedure, at 30 days, and at 12 months. Participants are expected to follow a specified follow-up schedule to provide data on device safety and performance throughout the study duration, which runs until November 2031.

Researchers are studying how gastrointestinal GI symptoms develop in patients with anorexia nervosa AN and bulimia nervosa BN during multi-week inpatient weight rehabilitation. The study focuses on how different dietary approachesflexitarian, vegetarian, or veganrelate to changes in GI symptoms throughout treatment. It also examines how weight gain, clinical factors, psychological status, and demographic details influence GI symptoms over time. The main goal is to understand symptom changes from admission to discharge using a GI symptom severity score, with analyses done separately for AN and BN groups. Participants are patients with AN or BN undergoing standard inpatient treatment aimed at weight rehabilitation and normalizing eating behavior at a specialized eating disorder center. During their stay, patients follow usual diagnostic and treatment procedures while detailed data on dietary intake and GI symptoms are collected. GI symptoms are assessed upon admission, weekly during hospitalization, and at discharge. The study tracks other clinical measurements such as body weight, body composition, and psychological assessments. Participants complete weekly questionnaires about GI symptoms as part of their routine care. Researchers collect body weight, composition, and various psychological survey data at admission and discharge, with some tests repeated weekly. Laboratory tests including blood counts and metabolic panels are also gathered regularly. The primary outcome measures the change in GI symptoms from admission to discharge, while secondary analyses evaluate symptoms over time, dietary impact, and clinical predictors. The study plans to enroll about 150 AN and 35-40 BN patients, with total participation spanning their inpatient stay.

Researchers are evaluating the efficacy and safety of the drug levosimendan, taken orally, 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 measure the change in the 6-Minute Walk Distance, which reflects exercise capacity. This phase 3, randomized, double-blind study aims to improve understanding of treatment options for this condition. About 540 participants will be randomly assigned in a 21 ratio to receive either oral levosimendan or a matching placebo. Those who complete the initial study period of 26 weeks may be eligible to join an open-label extension lasting 52 weeks, during which all participants can receive levosimendan. The study carefully monitors participants throughout both phases to assess the effects of the treatment. Participants will undergo various assessments including the 6-Minute Walk Distance test, questionnaires like the Kansas City Cardiomyopathy Questionnaire to evaluate health status, and classification of physical ability using the New York Heart Association scale. Screening includes heart catheterization, echocardiograms, ambulatory heart rhythm monitoring, and exercise testing. Safety and clinical worsening events will be tracked. The total involvement may last beyond a year for those in the extension phase, ensuring thorough evaluation of outcomes and safety.

The VISTA Nova Study focuses on patients with aortic stenosis who are undergoing transcatheter aortic valve replacement TAVR. The goal is to assess the safety, performance, and long-term durability of the Navitor valve in a real-world setting. This observational study evaluates how well the device works and its impact on patient outcomes over time. Participants will receive the Navitor Transcatheter Aortic Valve using the FlexNav delivery system and the Navitor Loading System. The Navitor valve comes in five sizes to fit annulus diameters from 19 mm to 30 mm, and the delivery and loading systems are available in two sizes each. The procedure follows approved indications and involves specialized equipment to implant the valve. During the study, participants will be monitored at scheduled follow-up visits after their TAVI procedure to track outcomes such as overall survival and valve leakage. The primary outcomes measured include all-cause mortality and the presence of moderate or greater paravalvular leak at 30 days post-procedure. Participants are expected to return for all required follow-up visits to help researchers evaluate the valves long-term safety and effectiveness, with the study continuing through 2032.