Chivasso

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.

Myelodysplastic syndromes (MDS) are a group of blood disorders mainly affecting older adults, causing ineffective blood cell production leading to anemia and other blood-related issues. This trial focuses on patients with MDS who have a specific chromosome 5q deletion (del5q) and are dependent on red blood cell (RBC) transfusions. These patients have low to intermediate risk disease and have not responded well or cannot tolerate prior treatment with lenalidomide. The study aims to evaluate the effect of luspatercept, a drug that helps mature red blood cells, on reducing the need for RBC transfusions in this group. Participants will receive luspatercept injections under the skin every three weeks, starting at a dose of 1.0 mg/kg with the possibility to increase the dose up to 1.75 mg/kg. The study includes a screening period, followed by a two-year treatment phase where participants get these injections. After completing treatment, participants will undergo follow-up visits every 24 weeks for up to two years to assess ongoing clinical benefits. During the study, participants will be monitored closely with regular visits to check their blood counts and overall health. Researchers will measure how long participants can avoid RBC transfusions over 24 weeks and evaluate safety and other health outcomes. The total participation time includes screening, treatment for two years, and follow-up for an additional three years, ensuring comprehensive monitoring of treatment effects and safety.

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.