Ragusa

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 tracking patients with Fabry disease through an ongoing international observational program called the Fabry Registry. This registry collects routine clinical outcomes for patients regardless of whether they are receiving treatment. The study aims to better understand the diseases variability, progression, and natural history, including in women who carry one copy of the gene, and to help improve patient care by developing monitoring recommendations and reporting outcomes. Additionally, the registry evaluates the long-term safety and effectiveness of Fabrazyme4, a treatment used in Fabry disease. The registry includes a special pregnancy sub-registry for women with Fabry disease who are pregnant or have been pregnant. This sub-registry observes pregnancy outcomes and infant growth up to 36 months after birth, collecting medical and obstetric history and treatment details. No experimental treatments are given participants continue to receive their usual care as determined by their physicians. Data from both registries support regulatory requirements and ongoing research. Participants undergo regular clinical assessments and receive standard care from their doctors throughout the study. The research team collects data on disease progression, treatment effectiveness, pregnancy outcomes, and infant development. The study is observational, meaning no study drugs or procedures are administered. The total participation can last up to 33 years, allowing for long-term monitoring of safety and outcomes related to Fabry disease and pregnancy.

This research investigates the real-world use of 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 capabilities. Heart failure is a serious condition with high rates of hospitalizations and healthcare costs. The HeartInsight algorithm, validated in previous studies, monitors trends in seven physiological parameters to provide early warnings about worsening heart failure, aiming to improve patient management by alerting healthcare providers well in advance. Patients enrolled in this prospective, multicenter observational registry will be followed for 12 months across approximately 14 centers in Italy. The study does not require additional diagnostic tests beyond standard care. When HeartInsight issues an alert, a standardized workflow guides clinical responses such as device adjustments, therapy changes, or extra visits. Patients may also choose to use the HeartInsight Patient App to assist in monitoring. The study collects data on how often alerts occur, the clinical actions taken, patient interviews, and hospitalizations. Participants will have their device data remotely monitored and attend regular clinical visits as part of routine care. Researchers will track the proportion of alerts that lead to clinical actions and measure secondary outcomes like alert frequency, duration of alert periods, patient interviews, hospitalizations, and app usage. Data are collected securely via electronic forms and monitored for quality. The study aims to provide insights into integrating predictive monitoring tools into everyday practice to potentially enhance heart failure care over a 12-month period.

Researchers are conducting a multicenter observational study to collect 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. The study includes both retrospective and prospective cohorts to better understand diagnosis and management patterns of these conditions over time. The retrospective cohort gathers data from patients diagnosed between January 1, 2010, and August 31, 2021, while the prospective cohort includes those diagnosed from September 1, 2021, through September 1, 2025. Data collection is done through an electronic case report form accessible to participating centers on a dedicated platform. This design allows for comprehensive data analysis across multiple centers in Italy. Participants data will be analyzed to describe diagnosis and management practices at one year for the prospective cohort and at four years for the retrospective cohort. The study involves no treatment administration instead, it focuses on observational data collection. Patient involvement is limited to consent for data use, and researchers monitor clinical and biological information recorded during routine care. The study is sponsored by the Gruppo Italiano Malattie EMatologiche dellAdulto GIMEMA.