Résumé
Numerous phase III clinical trials in heart failure with impaired LVEF have demonstrated the effectiveness of new treatments. These treatments are discontinued at the end of the trial. We sought an association between the end of two international, randomized, double-blind, placebo-controlled trials and the occurrence of heart failure-related events. This single-center, retrospective analysisfound a trend toward an increase in the number of events after the end of the clinical trial with no statistically significant difference (HR= 1.64 with a 95% CI [0.64-4.21], p= 0.3). There was also a trend towards fewer events in patients who received the trial treatment, with no statistically significant difference (HR= 0.54 with 95% CI [0.15-191], p= 0.3). This trend could be confirmed by extending the analysis to other centers, thus increasing the number of subjects. This study also raises the question of how practitioners can manage the end of clinical trials in severe chronic diseases such as advanced heart failure. There is currently no legal requirement for sponsors to provide posttrial provisions after the end of the trial, although some international texts refer this.