Heart failure & cardiomyopathiesSecondary analysis
Comparison of Investigator-Reported and Centrally Adjudicated Heart Failure Outcomes in the EMPEROR-Preserved Trial
- Secondary analysis of the EMPEROR-Preserved randomised trial
Authors' conclusion
Investigator adjudication is an alternative to a CEC with similar accuracy and faster event accumulation in HFpEF. The use of granular (SCTI) criteria did not improve trial performance.
Study context
- Population
- Patients with heart failure with preserved ejection fraction (HFpEF) in the EMPEROR-Preserved trial
- Comparison
- Investigator-reported vs clinical events committee (CEC)-adjudicated heart failure (HF) outcomes
- Primary endpoint
- Concordance and treatment effect on primary composite outcome (first HHF or CV mortality)
Primary result
As reported in the abstract
Primary composite outcome:
- First HHF
- CV mortality
| Group | Treatment effect HR |
|---|---|
| Investigator reports | 0.77 (95% CI 0.69-0.87) |
| CEC | 0.79 (95% CI 0.69-0.90) |
- CEC confirmed investigator-reported primary outcome events
- 67.4%
- CEC confirmed CV mortality events
- 82.7%
- CEC confirmed HHF events
- 66.3%
Further findings
Prognosis after first HHF (all-cause and CV mortality)
- Did not differ between investigator reports and CEC
SCTI criteria in CEC HHFs
- SCTI criteria present in CEC HHFs, with treatment effect similar to non-SCTI
- 92%
Time to protocol target number of primary events
months
- Investigator reports reached target earlier than CEC
- 6
- Earlier than CEC with full SCTI criteria
- 7
Original publication
Comparison of Investigator-Reported and Centrally Adjudicated Heart Failure Outcomes in the EMPEROR-Preserved Trial. JACC Heart Fail. Published 29 January 2025. doi:10.1016/j.jchf.2024.10.021
Summarised from the published abstract; every number is checked against it