Cardiovascular

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.

TL;DR

APOSCREEN-1 is a prospective single-arm clinical trial evaluating the feasibility and diagnostic yield of a pharmacy-based multi-parametric screening for cardiovascular-kidney-metabolic risk factors in 1000 adults across 20 community pharmacies in Schleswig-Holstein, Germany.

Key Findings

Cardiovascular-kidney-metabolic (CKM) syndrome represents a major global health burden and is a leading driver of cardiovascular disease, the leading cause of death worldwide.

  • CKM syndrome oftentimes remains undetected until organ damage is clinically present
  • Effective management of CKM depends on timely identification of underlying risk factors
  • Participation rates in primary care-based screenings are described as low

APOSCREEN-1 is designed as a prospective, single-arm clinical trial conducted across 20 community pharmacies in the German state of Schleswig-Holstein.

  • The trial was registered with the German trial registry (Deutsches Register klinischer Studien) on 29.01.2026, under trial number DRKS00039149
  • Target enrollment is 1000 adult participants
  • Eligible participants must be aged ≥40 years with predefined risk criteria
  • Results are transmitted to the study center via an online platform

The screening protocol involves standardized point-of-care testing for multiple cardiovascular-kidney-metabolic risk parameters.

  • Point-of-care tests include glycated hemoglobin (HbA1c), lipid profile, urinary albumin, and blood pressure measurement
  • Clinical history is also assessed as part of the screening
  • Patients meeting pre-defined thresholds are followed up by confirmatory laboratory testing at the study center or at the participants' general practitioner

The primary outcomes of the trial 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, and evaluation of the clinical impact
  • The study aims to assess both feasibility and diagnostic yield of the pharmacy-based approach
  • Implementation metrics are assessed from the pharmacy perspective

Community pharmacies are identified as an accessible but underused setting for enhancing early detection of CKM syndrome risk factors outside traditional primary care settings.

  • The 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

What This Means

This research describes the design of a clinical trial called APOSCREEN-1, which tests whether community pharmacies can effectively screen people for cardiovascular, kidney, and metabolic health risks. The trial enrolls 1,000 adults aged 40 and older who visit any of 20 participating pharmacies in the Schleswig-Holstein region of Germany. During a pharmacy visit, participants receive quick on-the-spot tests for blood sugar control (HbA1c), cholesterol levels, protein in the urine (a kidney damage marker), and blood pressure — conditions that together make up what is called cardiovascular-kidney-metabolic (CKM) syndrome. People whose results fall outside healthy ranges are then referred for follow-up testing with a doctor or at the study center. The motivation for this study is that CKM syndrome — which significantly raises the risk of heart disease, kidney failure, and diabetes — often goes undetected until serious organ damage has already occurred. Standard health screenings through primary care doctors have low participation rates, meaning many at-risk people are missed. Pharmacies are visited frequently and are easily accessible to the public, making them a potentially powerful but currently underutilized setting for catching these conditions early. This research suggests that pharmacies could serve as a practical front-line detection point for serious but often silent health risks. The trial is designed to measure not only how many previously undetected or poorly managed conditions are found, but also how feasible and acceptable the screening process is from both the pharmacy staff's and participants' perspectives. The researchers note that future studies will be needed to determine whether structured follow-up care after pharmacy-based screening leads to better long-term health outcomes.

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Citation

Amelunxen E, Kokot A, Kolbrink B, Thomsen S, Meßtorff M, Laudes M, et al.. (2026). 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.. BMC nephrology. https://doi.org/10.1186/s12882-026-05090-x