APOSCREEN-1 - a prospective, single-arm clinical trial for the implementation of a pharmacy-based screening for cardiovascular-kidney-metabolic risk factors in Schleswig-Holstein.

内容摘要

Cardiovascular-kidney-metabolic (CKM) syndrome has emerged as a major global health burden and driver of cardiovascular disease (CVD), the leading cause of death worldwide. Effective management of CKM depends on timely identification of underlying risk factors. Nevertheless, participation rates in primary care-based screenings are low. Consequently, CKM syndrome oftentimes remains undetected until organ damage is clinically present. Community pharmacies offer an accessible, yet underused, setting to enhance early detection. APOSCREEN-1 evaluates the feasibility and diagnostic yield of a pharmacy-based multi-parametric screening for cardiovascular-kidney-metabolic health. APOSCREEN-1 is a prospective single-arm clinical trial conducted in 20 community pharmacies in the German state of Schleswig-Holstein. Adults (n = 1000) aged ≥ 40 years with predefined risk criteria are included. Participants undergo standardized point-of-care testing (glycated hemoglobin, lipid profile, urinary albumin, blood pressure). Additionally, clinical history is assessed and results are transmitted to the study center via an online platform. Patients meeting pre-defined thresholds of the tested parameters are followed up by confirmatory laboratory testing at the study center or at the participants' general practitioner. Primary outcomes include completion rate, implementation metrics from the pharmacy perspective, and the number needed to screen to detect unknown or insufficiently managed cardiometabolic risk factors. Secondary outcomes comprise participant metrics, diagnostic metrics of the screening, evaluation of the clinical impact. This study aims to address the unmet need for scalable prevention of CVD by identification of CKM syndrome risk factors outside traditional primary care settings. Evidence on feasibility, acceptance, and diagnostic benefit may support the use of community pharmacies as an additional access point for early CKM syndrome detection. Future interventional studies will be required to evaluate structured follow-up pathways and long-term effectiveness. This study was registered with the German trial registry (Deutsches Register klinischer Studien) on 29.01.2026, under trial number DRKS00039149.