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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Heart failure with reduced ejection fraction HFrEF is a serious condition affecting many people worldwide and represents about half of all heart failure cases. This research aims to evaluate how well guideline-directed medical therapy GDMT is implemented in real-world hospital and outpatient settings after a specific physician training program within the German Helios hospital network. The study focuses on early in-hospital initiation and rapid up-titration of GDMT following the 2023 European Society of Cardiology guidelines, which recommend a combination of four drug classes to improve patient outcomes. The study observes patients hospitalized for HFrEF who receive treatment according to the Helios-GDMT program. Researchers will track the use and adjustment of recommended drug classes including ACE inhibitors, ARNI, beta-blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors from hospital admission through discharge and into routine outpatient care. The study is non-interventional and monitors how these guideline-based treatments are applied and maintained over time. Participants will be followed from hospital admission, with assessments around six days post-hospitalization at discharge, and then up to 12 months. Researchers will collect data on medication adherence, heart failure symptoms, rehospitalization, mortality, and patient-reported outcomes such as quality of life and health questionnaires. Regular post-discharge visits will be recorded, and changes in clinical measures like blood pressure, heart rate, and kidney function will be monitored to understand the real-world impact of the treatment program over one year.
Actively Recruiting
Researchers are evaluating the efficacy and safety of GLSI-100 immunotherapy in people with HER2neu positive breast cancer who are at high risk for the disease returning. The study focuses on participants who are HLA-A02 positive and have completed both neoadjuvant and postoperative adjuvant trastuzumab-based therapy. This Phase 3 trial includes a third open-label group for non-HLA-A02 positive subjects. Participants receive either GLSI-100 immunotherapy or a placebo through intradermal injections. The treatment schedule includes a Primary Immunization Series of 6 injections over the first 6 months, followed by 5 booster injections spaced 6 months apart, totaling 11 injections over 3 years. The open-label arm also receives GLSI-100 following the same injection schedule. During the study, participants will be monitored for invasive breast cancer-free survival over a median follow-up of 4 years, with interim analyses planned. Secondary outcomes include disease-free survival, overall survival, and quality of life assessments at baseline and 36 months. Safety and treatment effects will be evaluated throughout the trial, which is expected to continue until December 2026.
Actively Recruiting
Researchers are examining how three major heart conditionsheart failure, coronary artery disease, and atrial fibrillationare currently treated in everyday clinical practice. This observational registry study collects standardized patient data and outcomes to better understand healthcare use and how these diseases and their treatments interact. The study follows guidelines set by the International Consortium for Health Outcomes Measurement to ensure consistent and meaningful tracking of patient experiences and results. The study includes hospitalized patients diagnosed with any of the three heart conditions. There is no specific intervention or treatment assigned by the study instead, it observes how patients are treated in real-world clinical settings. Patients are grouped based on their diagnosis of heart failure, coronary artery disease, or atrial fibrillation. The research team collects data during hospital stays and follows patients over time to monitor health outcomes and treatment effects. Participants will have their health status and outcomes tracked through regular assessments over periods of 6, 12, and 18 months. These evaluations include measurements of all-cause and cardiovascular mortality, rates of hospital readmissions, length of hospital stay, quality of life surveys, side effects related to medications, and adherence to treatments. The study also monitors complications from therapies and the associated costs, providing a detailed view of patient experiences and health outcomes in real-world care over time.