Non-eligibility for pivotal HFpEF/HFmrEF outcome trials and mortality in a contemporary heart failure cohort

•Heart failure with mildly reduced or preserved ejection fraction (HFpEF, HFmrEF) are fatal diseases.•Criteria of 6 pivotal drug trials for HFpEF/HFmrEF were applied in a real-world heart failure cohort.•Trial non-eligibility was overall common and due to selective exclusion criteria.•Non-eligibilit...

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Published in:European journal of internal medicine 2023-12, Vol.118, p.73-81
Main Authors: Santner, Viktoria, Riepl, Hermann S., Posch, Florian, Wallner, Markus, Rainer, Peter P., Ablasser, Klemens, Kolesnik, Ewald, Hoeller, Viktoria, Zach, David, Schwegel, Nora, Kreuzer, Philipp, Lueger, Andreas, Petutschnigg, Johannes, Pieske, Burkert, Zirlik, Andreas, Edelmann, Frank, Verheyen, Nicolas
Format: Article
Language:English
Subjects:
Heart Failure - therapy
Heart failure with mildly reduced ejection fraction
Heart failure with preserved ejection fraction
Humans
Mortality
Prognosis
Randomized controlled trial
Stroke Volume
Trial design
Trial eligibility
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Summary:•Heart failure with mildly reduced or preserved ejection fraction (HFpEF, HFmrEF) are fatal diseases.•Criteria of 6 pivotal drug trials for HFpEF/HFmrEF were applied in a real-world heart failure cohort.•Trial non-eligibility was overall common and due to selective exclusion criteria.•Non-eligibility was associated with higher mortality throughout all trials.•Pivotal trials in HFpEF/HFmrEF likely systematically excluded high-risk patients. Pivotal outcome trials targeting heart failure with preserved (HFpEF) and mildly-reduced ejection fraction (HFmrEF) may have excluded patients at highest risk of poor outcomes. We aimed to assess eligibility for HFpEF/HFmrEF outcome trials in an unselected heart failure cohort and its association with all-cause mortality. Among 32.028 patients presenting to a tertiary care center emergency unit for any reason between August 2018 and July 2019, we identified 407 admissions with evident HFpEF and HFmrEF. Eligibility criteria for pivotal trials CHARM-Preserved, I-PRESERVE, TOPCAT, PARAGON-HF, EMPEROR-Preserved and DELIVER were assessed by chart review. The proportions of admissions fulfilling HFpEF/HFmrEF trial eligibility criteria were 88% for CHARM-Preserved, 40% for I-PRESERVE, 35% for TOPCAT, 28% for PARAGON-HF, 51% for EMPEROR-Preserved, and 49% for DELIVER. During a median follow-up of 1.9 years, death-from-any-cause occurred in 121 cases (30%). Twenty-four-month overall survival estimates for non-eligible and eligible admissions were 53% vs. 76% for CHARM-Preserved (HR=2.32, 95% CI: 1.47–3.67, p
ISSN:0953-6205
1879-0828
DOI:10.1016/j.ejim.2023.07.027