Ragusa

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 tracking patients with Fabry disease through an ongoing international, multi-center observational program called the Fabry Registry. This program collects routine clinical data from patients regardless of their treatment status to better understand the disease's variability, progression, and natural history. It also focuses on enhancing patient care by supporting the development of monitoring recommendations and evaluating the long-term safety and effectiveness of Fabrazyme, a treatment for Fabry disease. The study includes a Fabry Pregnancy Sub-registry, which is a voluntary, international, longitudinal observation program that monitors pregnancy outcomes for women enrolled in the Fabry Registry who are pregnant or have been pregnant. This sub-registry collects medical and obstetric history, pregnancy, and birth data, along with infant growth information up to 36 months postpartum, regardless of the specific treatment received. No experimental treatments are administered in either registry; patients continue receiving routine care as determined by their physicians. Participants contribute data through clinical assessments and standard care evaluations performed by their doctors. The study measures long-term outcomes including safety and effectiveness of Fabrazyme over up to 33 years, as well as pregnancy outcomes and infant growth data. The program helps fulfill regulatory requirements and supports research while tracking patient health over extended periods without altering their usual care.

Researchers are evaluating the HeartInsight algorithm, designed to predict acute heart failure events in patients with implanted Biotronik ICD or CRT-D devices that have atrial sensing and Home Monitoring. Heart failure is a serious condition with high rates of hospitalizations and healthcare costs. HeartInsight analyzes trends in seven physiological variables to provide early warnings of worsening heart failure, with a median lead time of 42 days. This study aims to assess how HeartInsight alerts are managed in routine clinical practice across multiple centers in Italy. About 100 patients will be enrolled across 14 centers and followed for 12 months. Participants have implanted devices with Home Monitoring and will be monitored remotely. When HeartInsight generates an alert, a standardized workflow guides clinical responses such as device adjustments, therapy optimization, unscheduled visits, or hospital admissions. The study collects data on alert frequency, clinical actions triggered, and patient use of the HeartInsight Patient App. Participants will provide informed consent and undergo standard remote monitoring and clinical visits. Data will be gathered through electronic case report forms, focusing on the proportion of alerts that lead to clinical actions, alert patterns, hospitalizations, and app usage. Safety and data quality will be monitored throughout. The study results aim to improve integration of predictive monitoring into patient care, potentially enhancing management and outcomes for heart failure patients.

Researchers are collecting clinical and biological data from patients newly diagnosed with Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), or CLL-like Monoclonal B-Cell Lymphocytosis (MBL) to better understand diagnosis and management. This observational study is conducted across multiple centers in Italy by the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) and includes both retrospective and prospective patient groups. The retrospective group consists of patients diagnosed from January 1, 2010, to August 31, 2021, while the prospective group includes those diagnosed between September 1, 2021, and September 1, 2025. The study involves collecting data through electronic case report forms accessible to participating centers on a dedicated platform. The retrospective cohort focuses on gathering past patient information, whereas the prospective cohort enrolls newly diagnosed patients during the study period. No interventions or treatments are assigned; instead, the study observes and records existing clinical and biological information based on established diagnostic criteria from WHO 2007 and 2018. Participants will be followed to describe their diagnosis and management, with outcomes assessed at one year for the prospective cohort and four years for the retrospective cohort. Data collection includes clinical evaluations and biological assessments recorded electronically. The study aims to provide comprehensive insights into CLL and related conditions over time, supporting improved understanding and care.