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Santner, V; Riepl, HS; Posch, F; Wallner, M; Rainer, PP; Ablasser, K; Kolesnik, E; Hoeller, V; Zach, D; Schwegel, N; Kreuzer, P; Lueger, A; Petutschnigg, J; Pieske, B; Zirlik, A; Edelmann, F; Verheyen, N.
Non-eligibility for pivotal HFpEF/HFmrEF outcome trials and mortality in a contemporary heart failure cohort.
Eur J Intern Med. 2023; 118:73-81 Doi: 10.1016/j.ejim.2023.07.027
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Leading authors Med Uni Graz: Riepl Hermann Stefan; Santner Viktoria; Verheyen Nicolas Dominik
Co-authors Med Uni Graz: Ablasser Klemens; Höller Viktoria; Kolesnik Ewald; Kreuzer Philipp; Lueger Andreas; Pieske Burkert Mathias; Posch Florian; Rainer Peter; Schwegel Nora; Wallner Markus; Zach David; Zirlik Andreas
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Abstract:: 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<0.001), 62% vs. 87% for I-PRESERVE (HR=2.97, 1.85-4.77, p<0.001), 67% vs. 84% for TOPCAT (HR=2.04, 1.29-3.24, p = 0.002), 68% vs. 85% for PARAGONHF (HR=2.28, 1.33-3.90, p = 0.003), 64% vs. 81% for EMPEROR-Preserved (HR=1.90, 1.27-2.84, p = 0.002), and 65% vs. 80% for DELIVER (HR=1.71, 1.14-2.57, p = 0.010). Exclusion criteria independently predicting death were eGFR <20 ml/min/1.73 m², COPD with home oxygen therapy, and severe valvular heart disease. Conclusively, in a contemporary HFpEF/HFmrEF cohort, non-eligibility for outcome trials predicted for strongly increased mortality. HFpEF/HFmrEF patients at highest mortality risk were likely underrepresented in previous outcome trials and their treatment remains an unmet medical need.
Find related publications in this database (using NLM MeSH Indexing): Humans - administration & dosage; Stroke Volume - administration & dosage; Prognosis - administration & dosage; Heart Failure - therapy
Find related publications in this database (Keywords): Heart failure with preserved ejection fraction; fraction; Randomized controlled trial; Trial eligibility; Trial design; Mortality; Heart failure with mildly reduced ejection