Relationship between dysglicemia and target organ damage: preliminary results from CV-PREVITAL trial

CV-PREVITAL (NCT05339841) is a large, randomized controlled trial designed to compare the effectiveness of a mobile health (mHealth) intervention versus usual care in reducing cardiovascular risk (BMJ Open 2023; 13(7):e072040). The study employed a multi-cohort design, including general medicine, pharmacies, IRCCS affiliated with the Italian Cardiology Network, and recruited approximately 28,000 men and women (56%) aged ≥45 years. Despite standardized data collection procedures, variations could arise due to the different recruitment settings. To assess the impact of this, we performed a preliminary analysis stratified by sex aimed at evaluating whether combining data from all cohorts into a single dataset has the potentiality to yield high-quality data capable of revealing well-established relationships among dysglicemia and variables related to target organ damage such as subclinical atherosclerosis, nephropathy, erectile dysfunction, valve disease, and pacemaker use. We found the all the anticipated associations between diabetes and target organ damage variables were statistically significant in both the overall study group and the sex-stratified analyses. In several analyses no differences were found between the prediabetes group and the control group regarding the association vs target organ damage variables. Overall, these results suggest a high quality of the gathered data. This finding, combined with the large sample size and the number of variables collected (>1000), suggests that CV-PREVITAL study will provide valuable insights not only into the effectiveness of digital intervention in primary cardiovascular prevention, but also into the relationship between prediabetes/diabetes and different types of target organ damage in the Italian population. Funding: Italian Ministry of Health (RCR-2019-23669116_001). On behalf of the CV-PREVITAL Study Group.