Heart failure & cardiomyopathies
Sex Differences in the Generalizability of Randomized Clinical Trials in Heart Failure with Reduced Ejection Fraction
Authors' conclusion
Generalizability of HFrEF RCTs differed substantially between the sexes, with females having lower trial participation and female trial participants having lower mortality rates compared to similar females in the registries, while males had higher than expected cardiovascular mortality rates in RCTs compared to similar males in registries.
Study context
- Population
- Patients with HFrEF in 2 heart failure (HF) registries and 5 HFrEF RCTs, stratified by sex2 registries · 5 RCTs
- Participants
- 16,917 / 26,104 / 20,810
- Comparison
- RCT vs RCT-eligible vs RCT-ineligible registry patients, by sex
- RCTn = 16,917
- RCT-eligiblen = 26,104reference
- RCT-ineligiblen = 20,810
- Outcome
- All-cause mortality, CV mortality and first HF hospitalization
- Follow-up
- 1 year
Pooled result
As reported in the abstract
All-cause mortality
SMR
0.72
95% CI 0.62–0.83
females, adjusted for 11 HF prognostic variables
SMR
1.16
95% CI 1.09–1.24
males, adjusted for 11 HF prognostic variables
RCT
- Females
- 5.6%
- Males
- 6.9%
RCT-eligible
- Females
- 14.0%
- Males
- 10.7%
RCT-ineligible
- Females
- 28.6%
- Males
- 24.6%
Females
RCT5.6%
RCT-eligible14.0%
RCT-ineligible28.6%
Males
RCT6.9%
RCT-eligible10.7%
RCT-ineligible24.6%
Further pooled results
CV mortality (adjusted for 11 HF prognostic variables) · 1 year
- Similar results for CV mortality, females: SMR
- 0.89; 95% CI 0.76-1.03
- Similar results for CV mortality, males: SMR
- 1.43; 95% CI 1.33-1.53
Original publication
Sex Differences in the Generalizability of Randomized Clinical Trials in Heart Failure with Reduced Ejection Fraction. Eur J Heart Fail. Published 18 May 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →