Desio

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating a cardiogenic shock protocol designed to improve communication and collaboration among hospitals to timely refer cardiogenic shock patients from spoke to hub centres in the Turin and Milan metropolitan areas. This observational study includes both a retrospective cohort from 2016 to 2019 and a prospective cohort starting in 2024. The purpose is to assess whether implementing this dedicated protocol reduces in-hospital or 30-day mortality in patients with acute myocardial infarction complicated by cardiogenic shock AMICS. Cardiogenic shock is a critical condition requiring rapid intervention and specialized care, and the study focuses on improving outcomes by optimizing patient transfer and treatment coordination. The study compares two groups one retrospective group of patients admitted before the protocol was implemented, and one prospective group admitted after the protocol adoption. Patients in the prospective cohort are managed under a standardized communication and referral protocol between spoke and hub centres, which include advanced cardiac interventions such as percutaneous mechanical circulatory support and prompt transfer to specialized teams. Hub centres have multidisciplinary shock teams, cardiac surgery backup, and 247 availability of cardiac care services. Spoke centres provide initial care and stabilization. The study involves 16 centres, with four hubs each receiving patients from three spoke centres. Participants will be monitored during their hospital stay and followed up to 30 days from admission. Data collected include clinical characteristics, treatments, timing of mechanical support device insertion, adverse events, and outcomes like mortality, stroke, bleeding, renal replacement therapy, vascular complications, and myocardial infarction. The study uses electronic health records and prospectively collected data, with no changes to standard care. The primary measure is 30-day mortality, and secondary outcomes include various clinical events and timing metrics related to treatment support. The study aims to provide insight into whether the hub-and-spoke protocol improves survival and quality of care for cardiogenic shock patients.

Reference intervals are important tools used to interpret laboratory test results. This research aims to evaluate indirect methods for determining these reference intervals using routine clinical laboratory data instead of relying on samples from actively recruited healthy individuals. The study focuses on improving accuracy and efficiency in defining reference intervals, particularly for complete blood count CBC parameters, and highlights the need for age-specific reference intervals due to variations in hemoglobin levels among the elderly. The study is observational and analyzes large-scale retrospective data collected from routine clinical laboratory tests across multiple Italian regions. It evaluates the RefineR statistical method, an open-source tool designed to distinguish normal from pathological data efficiently. The study will assess regional differences, establish age- and sex-specific reference intervals, and evaluate variations caused by different laboratory instruments over a period of up to three years. Participants are not actively recruited since the study uses existing laboratory data. Researchers will analyze these data to define reference intervals and compare results across regions, age groups, and testing platforms. The primary outcome is the definition of indirect reference intervals for CBC parameters. Secondary outcomes include assessments of regional and instrument variations. The study will run from October 2025 to June 2028, with no direct participant involvement beyond data analysis.