Heart failure & cardiomyopathies
Eligibility of Asian and European Registry Patients for Phase III Trials in Heart Failure with Reduced Ejection Fraction
Authors' conclusion
Based on 14 trial criteria, only one-fifth of registry patients were eligible for phase III HFrEF trials. Overall eligibility rates did not differ between the Asian and European patient cohorts.
Study context
- Population
- Phase III heart failure (HF) trials registered on ClinicalTrials.gov to end of 2021; HF with reduced ejection fraction (HFrEF) registry patients (Asian and European)163 HFrEF trials
- Participants
- 4,868 vs 2,545
- Exposure
- Eligibility of ASIAN-HF vs BIOSTAT-CHF registry patients for phase III HFrEF trials
- ASIAN-HFn = 4,868
- BIOSTAT-CHFn = 2,545reference
- Outcome
- Patient eligibility for HFrEF trials as a proportion of registry patients
Methodological detailsnatural language processing of trial eligibility criteria, registry-based, Of 375 phase III HF trials, 163 HFrEF trials identified, Based on 14 trial criteria
- Natural language processing of trial eligibility criteria
- Registry-based
- Of 375 phase III HF trials, 163 HFrEF trials identified
- Based on 14 trial criteria
Main finding
As reported in the abstract
Eligibility for HFrEF trials
ASIAN-HF
0.20
median · IQR 0.08–0.43
BIOSTAT-CHF
0.17
median · IQR 0.06–0.39
P = 0.18
- Average eligibility of registry patients for HFrEF trials
- 20%
Observational data: associations, not effects.
Further findings
Eligibility over time
- Eligibility 1985-2005
- 0.40
- Eligibility 2016-2022
- 0.19
- Decline over time
- P = 0.03
Most frequent inclusion criteria in HFrEF trials
- New York Heart Association (NYHA) class
- 69%
- Worsening HF
- 23%
- Natriuretic peptides
- 18%
Most frequent comorbidity-based exclusion criteria
- ACS
- 64%
- Renal disease
- 55%
- Valvular heart disease
- 47%
Most restrictive criteria (weighted by frequency)
- Prior MI, NYHA class, age, prior HF hospitalization
Original publication
Eligibility of Asian and European Registry Patients for Phase III Trials in Heart Failure with Reduced Ejection Fraction. ESC Heart Fail. Published 10 July 2024. doi:10.
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