Probabilistic Readjudication of Heart Failure Hospitalization Events in the PARAGON-HF Study.

As previously reported, PARAGON-HF narrowly missed statistical significance for its primary end point (rate ratio, 0.87 [95% CI, 0.75-1.01]; I P i =0.059).[2] It is noteworthy that 28% (566 cases) of potential HF hospitalizations identified by investigators were negatively adjudicated by the CEC. This mean probability for each event was then used in a multiple imputation procedure, creating 1000 imputed data sets with CEC-unconfirmed events included or not based on their probability (random draw from a respective Bernoulli distribution), such that an event with an average probability of 40% would be expected to be included as a HF hospitalization in 400 of 1000 data sets. Keywords: clinical trial; heart failure; hospitalization; probability; sacubitril-valsartan; valsartan EN clinical trial heart failure hospitalization probability sacubitril-valsartan valsartan 2316 2318 3 06/10/21 20210608 NES 210608 Heart failure with preserved ejection fraction is a highly morbid condition with few proven treatment options. [Extracted from the article]