Enna

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are studying women who carry mutations in the BRCA1 or BRCA2 genes, which increase the risk of developing breast and ovarian cancers. Despite many studies over the past two decades, the best ways to manage these mutation carriers are still not fully established. In Italy, about 140,000 to 150,000 individuals carry these mutations, and it is estimated that 87% of women with these mutations will develop a genetically linked tumor during their lifetime. Approximately 20% of ovarian cancer cases in Italy each year have a genetic origin and could benefit from preventive approaches. Currently, there is no national prospective data collection specifically for women with BRCA mutations in Italy.

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 research aims to evaluate the use of HIV pre-exposure prophylaxis (PrEP) in Italy by establishing a large prospective cohort of HIV-negative adults who are sexually active and eligible for PrEP. The study focuses on assessing PrEP's effectiveness, tolerability, adherence, and barriers to long-term use in a real-world setting. It also monitors the incidence of new HIV infections and other sexually transmitted infections (STIs), along with psychological, behavioral, and treatment factors related to PrEP use. Participants include about 5,000 adults aged 18 years or older who are either starting or already using PrEP according to national and international guidelines. The study is conducted across 49 university and hospital infectious disease clinics and 4 community-based checkpoints throughout Italy. Participants attend routine clinical visits every 3 to 5 months, where they undergo HIV and STI testing, safety laboratory tests, and complete electronic questionnaires through a dedicated mobile app. The study will continue for at least 10 years and is coordinated by the National Institute for Infectious Diseases "L. Spallanzani" IRCCS in Rome. During the study, researchers collect sociodemographic, clinical, laboratory, behavioral, and quality-of-life data in a secure electronic case report form managed by the ICONA Foundation. The main outcome measured is the incidence of HIV seroconversion from enrollment onward. Secondary outcomes include monitoring STIs, evaluating PrEP safety and tolerability, and analyzing adherence, persistence in care, and related behavioral factors. Ethics committees at all participating centers have approved the study, ensuring participant safety and confidentiality throughout the long-term follow-up.