Randomization and blinding
After their consent, the patients were randomly assigned in a 1:1 ratio to either the intervention or control group. The randomization was performed centrally, using a computer-automated randomization system to guarantee adequate allocation concealment. The trial used a permuted block randomization scheme stratified by center, NYHA class, sex, and age (18–65, ≥ 66) to ensure equal representation in the groups.Due to the nature of the trial protocol, the patients and researchers could not be blinded, as they are both aware of the allocation due to their active role in the intervention. However, all assessments are undertaken by assessors blinded to treatment allocation.