Striking the Right Balance in Heart Failure

Unbelievable Folly of Clinical Trials in Heart Failure

“…I was one of the 2 principal investigators of a trial, 24 which demonstrated the survival benefits of adding a neprilysin inhibitor to an inhibitor of the renin-angiotensin system. Despite favorable opinions from unconflicted external reviewers supporting its adoption as first-line therapy, [25][26][27] the results from the study have been described as providing evidence from only a single-randomized trial. For some, 28,29 for sacubitril/valsartan to receive a class IA recommendation, the findings of the mortality trial with the drug would need to be replicated, although it is difficult to understand how this could be ethically accomplished, especially it were only to serve some artificial administrative purpose.…”