PREcision meDICine in Treatment in CardioVascular Disease

The PREDICT-CVD is a prospective, randomized controlled, open label, multinational trial, in which patients with HF will be randomized to either the control arm or the intervention arm. The control arm is the standard of care and the intervention arm is where an AI-derived biomarker-guided treatment algorithm will be applied, to assist the treating professional in treatment decision. Assessment of the primary endpoint will be at the 9 month onsite follow-up visit, further long-term outcomes will be collected via telephone visits every 6 months until the last subject has completed the 9 month onsite follow-up. The main objective is to demonstrate that a personalized, AI-derived biomarker-guided medication treatment algorithm that provides advice to the treating HF professional is superior to prevent clinical events and improve quality of life (QoL) when compared to patients receiving standard treatment of care. The primary outcome of the trial is a clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and or a greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 9 months, as assessed using a win ratio. The expected duration for patients will be between 9 and max 24 months from the moment of enrollment. From 9 months onwards patients will be contacted by phone every 6 months and information regarding (HF) events and concomitant medication will be collected.