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Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are investigating whether tumor and lymph node downstaging after neoadjuvant chemo-immunotherapy is linked to better surgical outcomes in patients with clinical stage IIB-III non-small cell lung cancer NSCLC. This observational study focuses on patients undergoing robotic-assisted thoracic surgery and aims to understand if this downstaging improves surgery success and recovery. Participants receive neoadjuvant chemo-immunotherapy, which includes PD-1PD-L1 inhibitors combined with platinum-based chemotherapy, sometimes with added radiation therapy before surgery. After treatment, they undergo robotic-assisted lung surgery with systematic lymph node removal. The study collects data on surgical completeness, extent of resection, any conversion to open surgery, complications, hospital stay length, readmission, and mortality. During the study, researchers gather clinical, surgical, pathological, and postoperative outcome information. Participants have baseline and restaging chest scans before surgery, and follow-up extends to 90 days after surgery to monitor complications and recovery. The main outcome measured is complete tumor removal, with additional monitoring of hospital stay duration, postoperative problems, readmission rates, and mortality within 30 and 90 days.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Myelodysplastic syndromes MDS primarily affect older adults and involve problems with blood cell production, leading to anemia, low white blood cells, and low platelets. These conditions often cause patients to depend on red blood cell transfusions and carry risks like infection and bleeding. This research evaluates luspatercept, a protein designed to help mature red blood cells, in adults with MDS who have a specific chromosome deletion del5q and who are resistant or intolerant to prior treatments like lenalidomide. The study focuses on patients with low to intermediate risk MDS and aims to assess whether luspatercept can reduce the need for transfusions. Participants will receive luspatercept injections under the skin every three weeks, starting at a dose of 1.0 mgkg, with possible increases up to 1.75 mgkg. The study has a screening period, followed by a two-year treatment phase where patients receive the drug and are closely monitored. After treatment, there is a three-year follow-up to observe longer-term effects. Researchers will track responses such as transfusion independence, hemoglobin levels, quality of life, and safety during and after treatment. Throughout the study, participants will have regular visits for assessments including blood tests, quality of life questionnaires, and monitoring for side effects. The main outcome is whether patients achieve at least eight weeks without needing red blood cell transfusions within the first 24 weeks. Additional measures include long-term transfusion independence, duration of response, reduction in transfusions, changes in iron levels, and overall safety over five years. The total participation lasts up to five years, ensuring comprehensive evaluation of luspatercepts effects.

Researchers are evaluating the EuroHeart program, an observational and prospective multicenter initiative designed to improve quality of care for patients with common cardiovascular diseases such as Acute Coronary Syndrome ACS, heart failure, and atrial fibrillation. EuroHeart collects standardized and harmonized patient data to support continuous quality improvement by monitoring adherence to quality indicators defined by the European Society of Cardiology ESC. The program aims to understand how well proven treatments are applied in everyday clinical practice. The study involves continuous data collection from consecutive patients hospitalized or treated for these cardiovascular conditions. Participants enter a 12-month follow-up period during which clinical events and health status data are gathered. This registry specifically evaluates adherence to ESC quality indicators in Italian clinical practice, including measures such as time to reperfusion and prescription of recommended medications at discharge. Participants will be monitored through regular collection of clinical data over the 12 months following enrollment. Researchers will assess adherence to multiple ESC quality indicators related to treatment and management of STEMI and NSTEMI patients, including evaluations of left ventricular function, lipid levels, and use of dual antiplatelet therapy and other medications. The study also tracks cardiovascular and non-cardiovascular events during follow-up to support quality improvement efforts. Participation involves consent and data collection without experimental treatments.

Researchers are evaluating treatments for children and young adults with high-risk neuroblastoma, a type of cancer affecting nerve tissue. This trial involves patients with certain advanced stages of neuroblastoma, including those with specific genetic markers that indicate a higher risk of relapse. The goal is to assess different chemotherapy regimens, stem cell procedures, surgery, radiation, and immunotherapy combinations to improve outcomes such as event-free survival and metastatic response. The treatment plan includes an intensive chemotherapy induction phase called Rapid COJEC or a modified N7 regimen, followed by peripheral blood stem cell harvest and surgery to remove the primary tumor. Patients then receive myeloablative therapy with either busulfan plus melphalan or another chemotherapy combination, followed by stem cell rescue and radiotherapy. Immunotherapy involves the antibody ch14.18CHO given as a continuous infusion, with or without the immune stimulant Aldesleukin IL-2, alternating with isotretinoin. Some patients may receive additional chemotherapy cycles if needed, and treatment adaptations are made based on disease response and randomization results. Participants undergo regular assessments including evaluation of tumor response, event-free survival over up to three years, and metastatic response within about three months of induction therapy. Biological tumor markers and safety monitoring are also conducted. The study includes up to five years of follow-up to track long-term outcomes and monitor for disease progression or relapse. Treatments and evaluations are carefully scheduled to gather comprehensive data on the effectiveness and safety of these therapies in high-risk neuroblastoma.

Researchers are evaluating whether using virtual reality VR alongside standard sedation can reduce pain and improve the experience for patients undergoing pacemaker or defibrillator implantation. This study focuses on acute pain, vital signs, and patient satisfaction during these cardiac electrophysiology procedures. The goal is to see if VR can decrease discomfort, stabilize vital signs, and support same-day discharge after minimally invasive cardiac device implantation. Participants will be randomly assigned to one of two groups. One group will use a VR headset showing immersive natural landscapes with relaxing music starting at least five minutes before the procedure and continuing throughout, unless complications like nausea occur. The other group will receive standard sedation following hospital protocols, which may include medications like midazolam or fentanyl. During the procedure, researchers will monitor pain using a numeric rating scale and track vital signs including blood pressure, heart rate, respiratory rate, and oxygen levels. Patient satisfaction and length of hospital stay will also be assessed. The study involves close monitoring throughout the procedure and follow-up lasting about a week to observe outcomes and safety.

This research aims to improve treatment for children and adolescents newly diagnosed with lymphoblastic lymphoma. The trial is a large, international, randomized clinical study involving multiple countries and specialized centers. It focuses on whether using dexamethasone instead of prednisone during the induction phase can reduce relapses in the central nervous system CNS, and for high-risk patients, whether an intensified treatment improves event-free survival compared to standard therapy. Participants are grouped by risk level based on disease characteristics like CNS involvement and genetic markers. All patients first receive a prednisone prephase, then are randomized to either standard induction with prednisone or experimental induction with dexamethasone. Treatment phases include consolidation, extra-compartment phases adjusted by risk group, reintensification for some groups, and maintenance therapy lasting up to 24 months. Patients with CNS involvement receive intensified intrathecal therapy without cranial irradiation. High-risk patients may undergo a second randomization to receive either standard or intensified treatment during later phases. During the study, patients undergo various treatments including chemotherapy drugs such as cyclophosphamide, methotrexate, and PEG asparaginase. Researchers monitor disease relapse involving the CNS and measure event-free survival over a maximum of 7.25 years. Secondary assessments include overall survival, treatment-related toxicity and mortality, adverse events, and molecular markers. The trial involves ongoing follow-up for safety and effectiveness outcomes throughout the study period, which can last several years.

Researchers are conducting the RICMAF Study, an observational, multicenter, non-drug study in Italy focused on Anderson-Fabry Disease AFD, a rare genetic disorder that affects multiple organs, especially the heart. The study aims to better understand AFDs clinical course, its cardiac complications, and the relationship between genetic mutations and disease progression. This research seeks to improve patient care by identifying early markers of heart involvement and predicting cardiovascular problems. The study collects data from patients diagnosed with AFD according to international guidelines, starting from January 1, 1981, through December 31, 2031. It includes both retrospective and prospective phases, gathering comprehensive clinical, genetic, laboratory, and imaging information through a national patient registry. Patients undergo regular assessments as part of their standard care, including cardiology evaluations, ECG, echocardiography, and cardiac MRI when appropriate. Participants contribute data during routine clinical visits without additional study-specific procedures. The research team collects information from medical records and follow-up visits, including family history, symptoms, genetic tests, and heart monitoring results. The primary outcome is to define the natural history of Fabry disease over an average follow-up of five years, while secondary outcomes focus on cardiac risk stratification, genotype correlations, and early diagnostic biomarkers. The study duration extends up to 10 years, with ongoing data analysis and publication of findings.