Heide

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction MI specifically ST-segment elevation MI STEMI or non-ST-segment elevation MI NSTEMI who also have multivessel coronary artery disease CAD and have undergone successful treatment of the culprit lesion with Percutaneous Coronary Intervention PCI. The study aims to compare physiology-guided complete revascularization to angiography-guided complete revascularization, focusing on both efficacy and safety outcomes. Participants are randomly assigned to one of two groups. One group receives physiology-guided PCI where the function of non-culprit lesions NCLs is assessed using resting full-cycle ratio RFR or fractional flow reserve FFR, with PCI performed on lesions meeting specific thresholds. The other group undergoes angiography-guided PCI, receiving routine staged PCI on all qualifying NCLs identified before randomization. Both approaches follow local practice standards for PCI. During the study, researchers monitor participants for a minimum of two years to assess the time to first occurrence of major cardiovascular events, including cardiovascular death, new MI, or ischemia-driven revascularization, as well as safety outcomes like significant bleeding, stroke, stent thrombosis, or kidney injury related to contrast use. The trial also includes an observational imaging study using optical coherence tomography in a subset of patients. Follow-up assessments will enable evaluation of both efficacy and safety over the study period.

Ulcerative colitis UC is a chronic inflammatory bowel disease causing inflammation and bleeding in the rectum and large intestine. This research aims to assess changes in disease activity in adults with moderate to severe UC who are treated with risankizumab in real-world clinical practice. The study will observe approximately 200 adult participants prescribed risankizumab by their physicians in Germany and Austria. Participants will receive risankizumab as prescribed by their doctors according to the approved local label and routine clinical care. The study does not introduce additional treatments or procedures beyond what is normally provided. Participants will be followed for up to 52 weeks while continuing their usual medication schedule. Throughout the study, participants will attend regular hospital or clinic visits as part of their routine care. Researchers will track the percentage of participants achieving symptomatic remission using the Partial Adapted Mayo Score over about 52 weeks. There is no expected added burden, and participants will receive standard monitoring and care during this period.

Researchers are evaluating the safety and performance of the Occlutech Atrial Flow Regulator device in patients with heart failure. This international, multicenter follow-up registry aims to identify unknown side effects and determine when this treatment is appropriate. The study focuses on patients with chronic symptomatic heart failure and monitors outcomes over a 36-month period after device implantation. Participants will receive the Occlutech Atrial Flow Regulator, which is an interatrial shunt device delivered through a catheter. Treatments and procedures follow clinical routine and device instructions, performed by experienced physicians at equipped centers. The study tracks device performance and cardiovascular events at 12, 24, and 36 months after implantation. During the study, participants will undergo assessments including vital signs, lab tests, quality of life questionnaires, ECGs, and echocardiograms. Researchers will measure major adverse cardiovascular and neurological events within one year, as well as heart function, exercise capacity, and medication changes over three years. Safety and efficacy will be closely monitored throughout the follow-up period.