Heart failure & cardiomyopathiesCross-sectional study
Global Heart Failure Epidemiology Versus Enrolment in Pivotal Trials: A Formidable Mismatch
- Cross-sectional study
Authors' conclusion
Pivotal HF RCTs generate evidence primarily from Europe and North America, and grossly under-represent Africa and Asia.
Study context
- Population
- Pivotal phase 3 heart failure (HF) randomized clinical trials (RCTs) shaping international guidelines vs global HF distribution (Global Burden of Disease 2021)
- Exposure
- Europe vs North America vs Asia vs Africa vs Central & South America
- Outcome
- Geographic representativeness: representation index (RI, regional trial sites to disease distribution) and participant-to-prevalence ratio (PPR, regional trial participants to disease distribution)
Main finding
As reported in the abstract
Geographic representation in pivotal HF RCTs
| Group | Representation index (RI) | Participant-to-prevalence ratio (PPR) |
|---|---|---|
| Europe | 2.41 | 2.69 |
| North America | 3.25 | 2.58 |
| Asia | 0.26 | 0.22 |
| Africa | 0.14 | 0.05 |
| Central & South America | 1.29 | 1.59 |
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| Global HF prevalence by region, 2021 | Asia 50% · Europe 18% · Africa 14% · North America 10% · Central & South America 8% |
- Global HF prevalence by region, 2021 — People with HF worldwide
- 55.4 million
Original publication
Global Heart Failure Epidemiology Versus Enrolment in Pivotal Trials: A Formidable Mismatch. Eur J Heart Fail. Published 28 May 2025. doi:10.1002/ejhf.3707
Summarised from the published abstract; every number is checked against it