Heart failure & cardiomyopathiesRandomised controlled trial

Analysis and Interpretation of a Hierarchical Outcome in a Small Pilot Randomized Trial: An Example in the CORTAHF Trial

Eur Heart J Cardiovasc PharmacotherPublished

  • randomized 100-patient CORTAHF pilot trial
  • post hoc hierarchical composite endpoints (HCE)
  • generalized pairwise comparisons (GPC)

Authors' conclusion

Patients’ ranks can be derived from GPC and used to estimate stratified and covariate-adjusted win statistics as well as to visualize the treatment effect. Use of a well-constructed HCE in a small pilot trial should be considered; a positive signal may support further examination of the treatment. A full analysis can aid in interpretation.

Study context

Population
Patients with acute heart failure (AHF) receiving short-term corticosteroid therapyrandomized patients in the CORTAHF pilot trial
Participants
100 patients

Primary result

As reported in the abstract

Individual components of the HCE (90-day HF readmission, 30-day WHF adverse events, 30-day change in EQ-VAS)
  • Beneficial prednisone effects suggested on 90-day HF readmission and 30-day WHF adverse events
  • Little effect on 30-day change in EQ-VAS

Further findings

HCE (90-day death, 90-day HF readmission, 30-day worsening HF, 30-day change in EQ-VAS)

win ratio
1.82
win odds
1.71
ties remaining
10%
overall win difference
26.1%
  • both p<0.05
  • HF readmission contributed most to the overall win difference
  • most comparisons were resolved at the last tier

Stratification and baseline covariate adjustment using patients' ranks

Feasible, but did not substantially alter the estimated win odds

Original publication

Analysis and Interpretation of a Hierarchical Outcome in a Small Pilot Randomized Trial: An Example in the CORTAHF Trial. Eur Heart J Cardiovasc Pharmacother. Published 7 October 2026. doi:10.1093/ehjcvp/pvag089

Summarised from the published abstract; every number is checked against it