Bad Nauheim

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 the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies IIM, including polymyositis PM and dermatomyositis DM. This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.

This research aims to assess the effectiveness and safety of adding oral anticoagulation OAC to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation POAF after isolated coronary artery bypass graft CABG surgery. The study is a prospective, multicenter, open-label, randomized trial comparing OAC with no OAC to evaluate the prevention of thromboembolic events and the risk of major bleeding. Participants are randomly assigned to either an OAC-based strategy using vitamin K antagonists or approved direct oral anticoagulants alongside antiplatelet therapy, or to an antiplatelet-only strategy. The anticoagulation treatment lasts for 90 days, with option for crossover to OAC if recurrent atrial fibrillation occurs after 30 days in the control group. Up to 500 patients may also participate in a digital health substudy using a wearable heart rhythm monitor for 30 days post-discharge. During the study, participants have follow-up visits at 30, 60, 90, and 180 days after randomization, including phone contacts and clinical assessments. Researchers will monitor outcomes such as death, stroke, transient ischemic attacks, myocardial infarction, thromboembolism, and bleeding events up to 180 days. Data from patients who decline randomization are collected in a parallel registry to compare baseline risk and treatment strategies.

Researchers are evaluating the LivIQ leadless pacemaker system in patients who need ventricular pacing according to Class I or II guidelines. This study aims to confirm the devices safety and performance, including a sub-study focused on its ability to maintain atrioventricular synchrony. The trial is open-label, prospective, single-arm, and conducted internationally across multiple centers. Participants will receive the LivIQ leadless pacemaker, implanted directly into the right ventricle. The study includes a main phase and an integrated atrioventricular synchrony sub-study, where specific heart rhythm data is collected at 1 and 6 months. Follow-ups occur at implant, pre-hospital discharge, 1, 3, 6, and 12 months, then every 6 months until market approval, with a remote 24-month visit after U.S. approval. Participants undergo regular on-site examinations and monitoring including device performance checks and health questionnaires. The study measures freedom from serious device-related effects, pacing adequacy, sensing performance, quality of life, battery longevity, and survival at 24 months. Participants are expected to complete all scheduled visits over the study duration, which may extend beyond two years.

This observational study evaluates the long-term outcomes, performance, and safety of BIOTRONIK devices used for conduction system pacing CSP in real-life clinical settings. It focuses on patients who receive these devices for cardiac pacing, including those with pacemakers, cardiac resynchronization therapy devices, or implantable cardioverter defibrillators, addressing conditions like bradycardia, tachycardia, and heart failure. Participants receive the Solia CSP S pacing lead for left bundle branch area pacing LBBAP as part of their routine care with BIOTRONIK devices. The study includes patients intended for new implantation or those recently implanted with investigational generators and leads positioned deep within the intraventricular septum. The study observes patients over an average of four years, monitoring device-related safety and electrical parameters through annual evaluations. Participants are involved in regular follow-up visits and use the BIOTRONIK Home Monitoring system via CardioMessenger to track device performance. Researchers measure rates of successful implantation, capture types, pacing thresholds, sensing amplitudes, and pacing impedance throughout the study. Safety is assessed by monitoring serious adverse device effects during the study period. The total participation time averages about four years, with annual assessments to support long-term device evaluation.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Researchers are evaluating whether performing percutaneous coronary intervention PCI on all significant blockages in patients with non-ST-segment elevation myocardial infarction NSTEMI and multivessel coronary artery disease is better than treating only the main culprit lesion. This open-label, randomized, controlled, multicenter trial aims to compare these two approaches to understand which provides better outcomes for patients with this heart condition. Participants will be randomly assigned to one of two groups. One group will receive optimal medical therapy and PCI only on the culprit lesion, with no further intervention on other blockages unless certain emergency criteria occur. The other group will receive complete revascularization of all significant non-culprit lesions, either during the initial procedure, hospitalization, or within 45 days after the initial PCI. During the study, participants will be followed for an average of two years to monitor outcomes including cardiovascular death, rehospitalization for heart attacks, and other heart-related events. Researchers will also assess quality of life and complications such as bleeding, stroke, and kidney injury at various time points. The study involves regular evaluations and aims to gather comprehensive data to determine the best treatment strategy for these patients.

Researchers are conducting a global, prospective, multi-center post-market clinical follow-up study called MANTRA to monitor the safety and performance of CORCYM devices and accessories used for aortic, mitral, and tricuspid valve diseases in real-world settings. This umbrella protocol allows multiple sub-studies to be added, covering the sponsors entire cardiac surgery heart valve portfolio and including core lab assessments for some products. The study plans to enroll about 2150 subjects across up to 130 sites worldwide. The study includes three sub-studies the Aortic Sub-Study, the MitralTricuspid Sub-Study excluding Memo 4D, and the Memo 4D Sub-Study. Subjects diagnosed with valve diseases and considered suitable for treatment with specific CORCYM devices can participate in the corresponding sub-study. Follow-up visits are planned at discharge, 30 days post-implantation, and annually for up to 10 years. The Memo 4D sub-study involves additional echocardiogram imaging assessed by a core lab. Participants will provide informed consent and share baseline, procedural, hospitalization, discharge, and follow-up data during standard medical care. They will complete quality of life questionnaires at baseline, 30 days, and one year. Researchers will monitor device success at 30 days as the primary outcome and track mortality, adverse cardiovascular events, rehospitalizations, valve function, and patient outcomes up to 10 years. Safety and performance data will be collected continuously throughout the study.

This research aims to study the effects of repetitive acute Cyclosporine A CsA bolus therapy in patients with Takotsubo syndrome TTS who have a high risk of poor outcomes. Takotsubo syndrome may be caused by excess catecholamines leading to heart inflammation and damage. Currently, there is no proven treatment for TTS, and this phase 2 randomized controlled trial will evaluate whether CsA can reduce heart injury and improve heart function compared to placebo. Participants will be randomly assigned to receive either Cyclosporine A or a placebo intravenously at baseline, 12 hours, and 24 hours after study inclusion. The treatment is given as a bolus dose based on body weight. The study will compare these two groups to see if CsA reduces heart muscle damage and improves the hearts ejection fraction. Secondary measures include heart inflammation, hospital stay length, and quality of life over a one-year follow-up. During the study, participants will have blood tests to measure heart damage markers like Troponin T at multiple time points up to 30 days. Heart function and inflammation will be assessed through imaging and clinical evaluations. Researchers will monitor participants for cardiovascular events, symptoms, depression, anxiety, and PTSD scores at 30 days and one year. The total participation includes close monitoring during the acute phase and follow-up assessments for one year.

This research aims to reduce preoperative anxiety and stress in patients undergoing elective cardiac surgery, as these factors can increase the risk of postoperative delirium, cognitive decline, and other complications. The study evaluates whether relaxation interventions using virtual reality and binaural beats can help prevent these mental health issues after surgery. It is a randomized controlled trial conducted at a single center involving 125 patients. Participants are randomly assigned to one of five groups four groups receive a 30-minute relaxation session before surgery with different combinations of natural sounds, binaural beats, and virtual reality nature scenes, while one group follows the standard procedure without any intervention. The relaxation interventions are delivered via headphones and, for some groups, a head-mounted display for the virtual reality experience. During the study, patients undergo neuropsychological exams and quality of life assessments before surgery, with stress markers like heart rate variability and saliva cortisol measured during the intervention. After surgery, daily delirium screenings are performed, and cognitive tests are repeated at hospital discharge and three months later. Researchers monitor various physiological and cognitive outcomes to assess the effects of the relaxation interventions on postoperative brain function and recovery.