Heart failure & cardiomyopathies

Centrally adjudicated vs. investigator-reported outcomes in randomized heart failure trials

Eur Heart JPublished Pooled analysis of randomised trials

Authors' conclusion

Positive adjudication rates were lower for heart failure events than cardiovascular death, but even negatively adjudicated heart failure events are prognostically important. Central adjudication of events did not alter the results (precision or estimated log(HR)), though some variation was observed, depending on the indication.

Study context

Population
CV outcome trials with >1000 patients including centrally adjudicated HF outcomes7 trials
Comparison
Centrally adjudicated vs investigator-reported outcomes
Outcome
Correlation of log(HR), centrally adjudicated vs investigator-reported events

Pooled result

As reported in the abstract

CV death: R2 (95% CrI 0.53-0.93)

.80

CV death or HF hospitalization: R2 (95% CrI 0.46-0.93)

.79

HF hospitalization: R2 (95% CrI 0.10-0.83)

.57

Further pooled results

Positive adjudication rates of investigator-reported events

CV death (range)
87.9%-99.2%
HF hospitalization (range)
61.6%-88.0%

Subsequent all-cause death after positively vs negatively adjudicated HF hospitalizations

Risk similar for positively and negatively adjudicated HF hospitalizations

Original publication

Centrally adjudicated vs. investigator-reported outcomes in randomized heart failure trials. Eur Heart J. Published 9 November 2024. doi:10.1093/eurheartj/ehae753

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