Ivrea

Researchers are studying the treatment LTP001 in two groups: healthy adults (Part A) and adults with pulmonary arterial hypertension (PAH) (Part B). The study aims to evaluate the safety, tolerability, and how the body processes LTP001 in healthy volunteers, and to assess the safety and effectiveness of LTP001 in participants with PAH. This trial includes a safety extension period for participants with PAH to monitor longer-term effects. In Part A, healthy adult participants will receive single and multiple ascending doses of LTP001 or placebo to assess safety and pharmacokinetics. Part B involves participants with confirmed PAH who will receive LTP001 or placebo alongside their standard PAH treatments. The study monitors participants from baseline through various treatment periods, including a treatment period of up to 106 weeks in Part B for long-term safety assessment. Participants will undergo evaluations including monitoring for adverse events and serious adverse events from baseline through Day 35 in Part A and through Week 106 in Part B. The study also measures changes in pulmonary vascular resistance (PVR) during Part B at Week 24. Assessments include physical exams, ECGs, and walking tests to evaluate heart and lung function. Researchers will track safety, efficacy, and tolerability throughout the study duration.

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

The trial investigates early stage Follicular Lymphoma (grades I-IIIA) in patients who have not received prior treatment. It is a prospective, multicenter, open-label, phase III randomized clinical trial comparing two treatment approaches. The study aims to evaluate the progression-free survival over up to 33 months, including a 9-month treatment period followed by 24 months of follow-up. Participants will be randomly assigned to one of two groups. The first group will receive standard involved-site radiation therapy at a dose of 24 Gy. The second group will receive the same radiation therapy followed by obinutuzumab infusions: 4 weekly doses and then 4 additional doses every 3 weeks, totaling 8 doses. This design allows comparison of radiation alone versus radiation combined with obinutuzumab. During the study, participants will have assessments including PET/CT scans for staging, bone marrow biopsies, and blood tests for specific lymphoma markers. Performance status will be monitored, and liver and kidney function will be evaluated. Safety and effectiveness will be tracked throughout treatment and for two years afterward. The main outcome measured is progression-free survival from treatment start through the follow-up period.

Researchers are evaluating a program called EuroHeart, developed by the European Society of Cardiology (ESC), which aims to improve care for patients with common heart conditions like Acute Coronary Syndrome (ACS), heart failure, and atrial fibrillation. This observational, prospective, multicenter initiative collects standardized patient data continuously in real-world clinical settings to support ongoing quality improvement. The focus is on how well healthcare providers follow ESC quality indicators proven to improve patient outcomes, addressing gaps between research and everyday practice. The study specifically looks at the Italian implementation of EuroHeart, monitoring adherence to ESC quality indicators in clinical care. It does not involve experimental treatments but collects detailed data on the management of patients hospitalized with ACS, heart failure, or atrial fibrillation. Participants' care is tracked throughout their hospital stay and beyond, with no additional interventions imposed by the study. Participants will be followed for 12 months after enrollment. During this period, researchers will collect data on clinical events, treatment adherence, and patient status to evaluate how well ESC quality indicators are met, such as timely reperfusion for STEMI patients and appropriate medication prescriptions at discharge. This long-term follow-up supports efforts to enhance care quality and patient outcomes in cardiovascular diseases.

Researchers are evaluating the use of Percutaneous Stellate Ganglion Block (PSGB) in patients experiencing arrhythmic storm, a serious emergency condition involving multiple sustained ventricular arrhythmias in 24 hours that do not respond to standard antiarrhythmic drugs. This international multicenter observational study, coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, aims to assess the safety and effectiveness of PSGB, which has limited large-scale evidence despite growing interest in neuromodulation treatments. Patients who meet the criteria will receive PSGB using one of two common approaches: the anatomical method, which targets Chassaignac's tubercle as the needle insertion point, or the echo-guided method. Depending on patient needs, the doctor may perform either a single injection of anesthetic or a continuous infusion via a catheter connected to a pump. This short-term study observes patients for 24 hours around the procedure. Participants’ arrhythmic episodes and the number of defibrillations will be recorded before and after PSGB to measure reduction in arrhythmic relapses within 12 hours post-procedure compared to 12 hours prior. Researchers will also track complications such as hematomas, vascular or nerve damage, and anesthetic side effects. Data will be collected electronically, and the study will monitor safety and effectiveness outcomes over time, potentially enrolling around 33 patients at the main center with expansion to other sites.

Researchers are conducting the RICMAF Study, an observational, multicenter research project in Italy, to better understand Anderson-Fabry Disease (AFD), a rare genetic disorder that affects multiple organs, particularly the heart. This disease is often underdiagnosed due to its nonspecific symptoms, which can lead to delays in treatment. The study aims to analyze the clinical profile, genetic factors, and progression of AFD, focusing especially on cardiac involvement, which is a major cause of mortality in affected patients. The study gathers data from a nationwide patient registry including approximately 800 patients diagnosed with AFD according to international guidelines. It includes both retrospective data collection from January 1981 to 2031 and prospective enrollment of new patients. Data comes from medical records and standard clinical evaluations such as specialist visits, laboratory tests, genetic analyses, and cardiac imaging. These evaluations are part of routine care and include assessments like ECG, echocardiography, and cardiac MRI. Participants will be followed over time to collect detailed information on symptoms, family history, genetic mutations, organ involvement, and treatment outcomes. Researchers will use this data to identify early markers of cardiac damage and predictors of cardiovascular complications. The study's primary measure is the natural history of Fabry disease from enrollment through an average follow-up of five years. The study ensures data privacy and follows ethical guidelines, with no additional costs for participants beyond usual care.

Researchers are studying patients who have cardiogenic shock caused by acute myocardial infarction or acute heart failure. The goal is to evaluate how a dedicated protocol, designed to improve communication and collaboration between spoke and hub hospitals in the Turin and Milan metropolitan areas, affects 30-day mortality rates. This multicenter observational study includes both a retrospective cohort from 2016 to 2019 and a prospective cohort from 2024 to 2026. The study focuses on patients classified as SCAI shock class B to D and aims to compare outcomes before and after the protocol's implementation. The study involves 16 centers, with four hub hospitals receiving patients transferred from spoke centers. The hub hospitals have specialized cardiogenic shock teams available 24/7 and advanced mechanical circulatory support devices. The protocol includes a stepwise communication checklist to facilitate timely diagnosis, referral, and transfer of patients requiring advanced care. Patients in the prospective cohort will be managed according to this protocol, while the retrospective cohort provides historical data for comparison. Participants will be monitored up to 30 days after hospital admission. Researchers will collect clinical data, treatments, complications such as stroke, bleeding, renal replacement therapy, vascular issues, and non-fatal myocardial infarction. They will also measure door-to-support time and symptom-to-support time. Data will be gathered from electronic health records and hospital charts, with outcomes adjudicated by an independent committee. Safety events and adverse effects will be tracked as well, with a focus on improving patient care and survival in cardiogenic shock.

Researchers are creating a large registry of patients with ATTR amyloidosis to better understand the disease's natural history in real-world settings. This study aims to define and validate models that predict disease progression and response to treatment at any stage. The registry will also promote collaboration among amyloidosis experts and physicians across Italy involved in diagnosing and managing systemic amyloidosis. The study involves collecting data from patients diagnosed or suspected to have systemic or localized amyloidosis. An online registry tool will be established to share this data with healthcare providers, facilitating diagnosis and treatment decisions. This network will enable physicians to access diagnostic resources through the ARTC and support ongoing patient management. Participants will provide informed consent and have planned or ongoing follow-up at participating centers. Data collected includes information at diagnosis and during follow-up visits. The primary outcome is to establish an online data-sharing tool accessible to healthcare providers over a five-year period. This approach aims to improve understanding, collaboration, and care for patients with ATTR amyloidosis.