Desio

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation 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.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

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.

Reference intervals are important for interpreting laboratory test results. Traditionally, these intervals are based on samples from healthy individuals, which requires recruiting volunteers and is costly and time-consuming. Advances in electronic health records and laboratory test data have made it possible to define these intervals indirectly, using routine clinical laboratory data instead of actively recruiting healthy subjects. Indirect methods analyze routine data to determine reference intervals more quickly and cheaply while avoiding the selection bias of very healthy populations. One advanced technique called RefineR offers accurate, robust, and efficient statistical modeling to separate normal from abnormal data. This method is available as an open-source tool and has been promoted by the International Federation of Clinical Chemistry and Laboratory Medicine for its benefits. The study aims to define indirect reference intervals for complete blood count parameters by analyzing large-scale retrospective laboratory data collected over up to 3 years. The research also considers age-related changes in hemoglobin levels, especially in older adults, to provide age-specific reference intervals that are currently lacking in many laboratory reports. This can improve diagnostic accuracy for patients of various ages.