Bad Nauheim

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Axial spondyloarthritis (axSpA) is an immune-related inflammatory disease mainly affecting the spine, causing chronic back pain and significantly impacting quality of life with symptoms like sleep problems, social isolation, and emotional distress. This research is evaluating the real-world effectiveness of the drug upadacitinib in controlling disease activity and managing pain in adults with active axSpA in Germany. Participants will receive oral upadacitinib tablets as prescribed by their doctors before joining the study, following local guidelines on dosage and treatment. The study will last about 52 weeks, during which participants will continue their prescribed treatment and attend regular medical visits as part of routine care. Throughout the study, researchers will monitor disease activity and treatment effects using medical assessments, side effect checks, and questionnaires. The main focus is on how many participants achieve and maintain low disease activity scores over 24 and 52 weeks, assessing both clinical and patient-reported outcomes related to pain and disease burden.

Researchers are evaluating the safety and effectiveness of subcutaneous anifrolumab compared with placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies (IIM), specifically polymyositis (PM) or dermatomyositis (DM). This multicenter, randomized, double-blind, placebo-controlled Phase III study adds anifrolumab or placebo to participants' standard of care treatment to assess overall disease activity. Participants will receive weekly subcutaneous injections of either anifrolumab or placebo for 52 weeks. After this period, all participants will receive open-label anifrolumab injections once weekly for an additional 52 weeks. This design allows researchers to evaluate initial treatment effects and longer-term outcomes with anifrolumab. During the study, participants will be monitored regularly for disease activity and safety. The main outcome measured is the Total Improvement Score (TIS) with a response defined as a score of 40 or higher at 52 weeks. The total study participation lasts up to 104 weeks, including the double-blind and open-label extension periods, ensuring comprehensive assessment of the treatment's impact and participant safety.

Researchers are evaluating the effectiveness and safety of adding oral anticoagulation (OAC) to standard antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. This phase 3, multicenter, open-label, randomized trial aims to compare the prevention of thromboembolic events like stroke or heart attack against the risk of major bleeding. Patients who decline randomization may join a parallel registry to capture their treatment choices and risk profiles. Participants will be randomly assigned to one of two groups: the OAC-based strategy group receiving oral anticoagulants such as vitamin K antagonists or direct oral anticoagulants combined with antiplatelet therapy, or the control group receiving antiplatelet therapy alone with aspirin or a P2Y12-inhibitor. The anticoagulation treatment is given for 90 days, with the possibility for patients in the control arm who develop recurrent atrial fibrillation after 30 days to switch to anticoagulation. The study follow-up includes visits at 90 days and phone calls at 30, 60, and 180 days. Up to 500 patients may participate in a digital health substudy using a wearable heart rhythm monitor for 30 days after discharge. During the study, researchers will monitor participants for serious events such as death, ischemic stroke, transient ischemic attack, myocardial infarction, and thromboembolism up to 180 days after randomization. Safety is assessed by tracking major bleeding events up to 90 days. Data from the registry group will be analyzed to compare risk profiles and treatment strategies. Participants will be evaluated through clinical visits, phone follow-ups, medical record reviews, and in some cases, digital monitoring to understand treatment effects and safety over time.

Researchers are studying whether performing percutaneous coronary intervention (PCI) on all significant blocked arteries (multivessel complete PCI) is better than treating only the artery causing the current heart attack (culprit-lesion only PCI) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) who have blockages in multiple heart arteries. This trial is designed as a prospective, randomized, controlled, and open-label study conducted at multiple centers to compare these two treatment approaches for people with NSTEMI and multivessel coronary artery disease. Participants will be assigned to one of two groups: one receiving PCI only on the artery responsible for the heart attack (culprit-lesion revascularization), and the other receiving PCI on all significant blockages in the heart arteries (complete PCI). The procedures involve opening blocked arteries using standard catheter-based techniques. The study will monitor participants over an estimated average of two years to evaluate outcomes. During the study, researchers will track the combined rate of cardiovascular death or rehospitalization for a new heart attack as the primary outcome. Participants will be followed closely for up to two years, with regular assessments and medical monitoring to capture these events. This approach aims to determine which PCI strategy leads to better long-term heart health and fewer complications.

Researchers are evaluating the ongoing safety and performance of CORCYM devices and accessories used to treat aortic, mitral, and tricuspid valve diseases in a real-world setting. This global, multi-center, prospective post-market clinical follow-up study, called MANTRA, uses an overarching Master Protocol that allows multiple sub-studies to be conducted and combined for comprehensive data collection. The study aims to provide long-term information on the heart valve products offered by Corcym S.r.l., a manufacturer specializing in solutions for cardiac surgeons. The trial includes three sub-studies focusing on different valves: the Aortic Sub-Study, the Mitral/Tricuspid Sub-Study (excluding Memo 4D), and the Memo 4D Sub-Study. Approximately 2,150 subjects will be enrolled worldwide, with treatments given according to the device instructions for use and at the investigator's discretion. The study collects data during standard medical care without additional interventions. The Memo 4D sub-study involves specialized echocardiogram imaging assessed by a Core Laboratory to monitor device performance and heart valve dynamics. Participants will be followed up at hospital discharge, 30 days after device implantation, and then annually for up to 10 years. Data collected include informed consent, baseline demographics and medical history, procedural details, hospitalization and discharge information, and follow-up data. Quality of life questionnaires will be completed at baseline, 30 days, and one year. The primary outcomes measure the number and percentage of subjects achieving device success 30 days after implantation. Safety events and device deficiencies will also be monitored throughout the study period.

This research aims to evaluate the effects of repetitive acute Cyclosporine A (CsA) bolus therapy in patients with Takotsubo syndrome (TTS) who have a higher risk of poor outcomes. The trial investigates whether CsA can reduce myocardial injury and improve heart function compared to placebo. TTS is thought to be caused by excess catecholamines leading to inflammation and heart damage, and currently, no evidence-based treatment exists. This study is a phase 2 multicenter randomized controlled trial designed to explore CsA's potential as a treatment option for TTS. Participants will receive either 2.5 mg/kg of Cyclosporine A or a placebo consisting of sodium chloride 0.9%, both given as intravenous boluses. These treatments are administered at baseline and then every 12 hours during the first 24 hours after study enrollment. The study compares the impact of CsA versus placebo on myocardial injury and other heart function parameters over time. During the study, researchers will measure heart muscle damage using high-sensitive Troponin T at multiple time points from baseline up to 30 days. They will also assess recovery of heart function, extent of heart swelling at 72 hours, length of hospital stay, and clinical outcomes at 30 days and one year. Participants will provide written consent and may undergo psychosocial and quality of life assessments. The follow-up lasts one year to monitor long-term effects and safety.

Patients undergoing cardiac surgery often experience anxiety and stress before the operation, which can increase the risk of mental problems like delirium or memory deficits after surgery. This research aims to reduce these preoperative stress levels using relaxation interventions involving virtual reality and binaural beats. The study is a randomized controlled trial conducted at a single center, enrolling 125 patients scheduled for elective cardiac surgery with extracorporeal circulation. Participants are divided into five groups: two groups receive a 30-minute preoperative relaxation session with natural sounds either with or without binaural beats delivered via headphones. Two additional groups receive a similar 30-minute relaxation session but with a 360-degree virtual reality nature scene combined with natural sounds, again either with or without binaural beats, using headphones and a head-mounted display. One group serves as the control and receives no such stimuli. On admission day, patients undergo detailed neuropsychological testing and quality of life assessments. During the 30-minute intervention, stress indicators such as cortisol levels, heart rate variability, and electrodermal activity are measured. After surgery, daily delirium screenings occur, with further neuropsychological exams and quality of life evaluations at hospital discharge and three months post-surgery. The main outcomes focus on changes in heart rate variability immediately before and after the intervention.

Researchers are evaluating the effects of various relaxation methods on stress and physiological responses in healthy adults not undergoing medical treatment. This non-clinical substudy is part of the DESTRESS research program, which primarily focuses on cardiac surgical patients. The study aims to understand the feasibility and potential stress-reducing effects of these approaches without influences from disease, surgery, or medication. Participants are randomly assigned to one of five groups: listening to natural soundscapes, natural soundscapes combined with binaural beats, experiencing virtual reality natural environments, virtual reality combined with binaural beats, or a control group with no relaxation intervention. Each participant takes part in a single session lasting about 30 minutes. During the session, physiological signals like heart rate variability and skin conductance are recorded continuously with non-invasive sensors. Before and after the session, participants complete standardized tests measuring neurocognitive function and self-reported stress levels. The main outcome measured is the change in high-frequency heart rate variability during the session. The study helps interpret results from the larger DESTRESS trial and explores how virtual reality and audio-based relaxation might reduce stress in a general adult population.

Researchers are evaluating the effects of continuing empagliflozin treatment during decongestive therapy for patients hospitalized with acute decompensated heart failure. This Phase 3 trial aims to determine if continuing empagliflozin is not worse than stopping it during hospitalization. The study focuses on patients already receiving SGLT2 inhibitors, assessing outcomes like mortality, heart failure events, and kidney function over 90 days. Participants are randomly assigned to receive either empagliflozin 10 mg daily or a matching placebo during their hospital stay for up to 30 days. After discharge but no later than day 31, all participants receive empagliflozin 10 mg daily until day 90. This approach compares ongoing empagliflozin treatment with temporary cessation during acute heart failure hospitalization. During the study, participants take one tablet daily from day 1 to day 90, limit fluid intake to 1.5 liters per day while recording daily intake from day 1 to day 6, and measure urine output over the same period. They also complete quality-of-life questionnaires at baseline, hospital discharge, and day 30. The primary outcome measures include a combined assessment of death, heart failure hospitalizations, and kidney function decline at 90 days.