Clinical validation

The primary objective of WP6 is to validate the models produced in WP5 by analysing the development, risk and progression of CVD, and Heart Failure.  
 
WP6 will aim to validate the most promising treatment response prediction model in a Phase 2B trial in the hopes of validating interaction between biomarker profile and treatment response determined in earlier WPs.

This means that treatment will be individually adjusted based on the biomarker profile and compared to a control group (who will receive standard care). Patients will be randomly allocated to one of these groups for 15 months, where the main outcome we will look for will be whether the biomarker guided treatment response leads to an improvement in CVD condition compared to standard care.  
 
Lastly, WP6 will also focus on continuing the prospective trial in type1 diabetes from WP1 but will enhance the intervention by validating the model produced in WP5 to predict patients most likely to benefit from cardio-renal protection therapy.