{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,25]],"date-time":"2026-06-25T20:05:31Z","timestamp":1782417931127,"version":"3.54.5"},"reference-count":50,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T00:00:00Z","timestamp":1781136000000},"content-version":"vor","delay-in-days":37,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>To determine whether control-arm event rates in heart failure (HF) randomized clinical trials (RCTs) published in New England Journal of Medicine from 2004 to 2024 declined over time, despite intensification of background therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We identified Phase 3 HF RCTs published in New England Journal of Medicine (2004\u201324). Annualized event rates were calculated as events divided by patients multiplied by follow-up to the primary endpoint. Temporal trends were analysed with weighted least squares (weights equal to the number of control-arm patients), with adjustment for follow-up duration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Thirty-eight trials met criteria; 31 enrolled HF with reduced ejection fraction (HFrEF; 82%). In HFrEF control arms, median age was 67 years [interquartile range (IQR) 64\u201369], women were 24% (IQR 21\u201330), left ventricular ejection fraction (LVEF) was 28% (25\u201331), N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 1700\u2005ng\/L (1273\u20132879), and the New York Heart Association (NYHA) class III\u2013IV was 46% (29\u201371). Background therapy included \u03b2-blockers 91% (82\u201393), angiotensin-converting enzyme inhibitors\/angiotensin receptor blockers (ARBs)\/angiotensin receptor\u2013neprilysin inhibitors 93% (90\u201397), and mineralocorticoid receptor antagonists (MRAs) 52% (42\u201359). The median control-arm size was 602 patients (308\u20131533). Across years, therapy use rose (\u03b2-blockers +1.04 percentage points per year, P &amp;lt; .001; MRAs +2.05 percentage points per year, P &amp;lt; .001), LVEF increased (+.22% per year, P = .012), NT-proBNP increased (\u223c+11.4% per year on the log scale, P = .004), and follow-up tended to shorten (P = .052). In control arms, all-cause mortality showed no temporal decline [unadjusted slope +.0019 per year; 95% confidence interval (CI) \u2212.0013 to +.0051; P = .252]; after adjusting for follow-up, the slope was +.0006 per year (P = .711). Longer follow-up was associated with lower annualized mortality (coefficient \u2212.0195 per year; P = .032). Cardiovascular mortality was stable (unadjusted +.0003 per year; 95% CI \u2212.0036 to +.0042; P = .898; follow-up\u2013adjusted \u2212.0012 per year; P = .557). The composite of all-cause death or HF hospitalization increased unadjusted (+.0180 per year; 95% CI +.0063 to +.0298; P = .011) but was not significant after follow-up adjustment (+.0113 per year; P = .111). Enrichment intensity did not rise linearly (coefficient +.032 criteria per year; P = .111), whereas natriuretic-peptide cut-offs were adopted more often [odds ratio (OR) per decade 14.09; 95% CI 1.93\u2013102.75; P = .009). Higher age related to higher mortality (coefficient +.0039 per year; P = .043). An interaction between year and log-transformed NT-proBNP indicated risk-dependent temporal patterns (P = .003).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In major HFrEF trials, control-arm mortality did not decline from 2004 to 2024 despite greater uptake of evidence-based therapy. Risk-enriched enrolment and shorter follow-up likely counterbalanced therapeutic gains.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/eschf\/xvag169","type":"journal-article","created":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T11:47:13Z","timestamp":1781092033000},"source":"Crossref","is-referenced-by-count":0,"title":["Event rates in major Phase 3 heart failure trials over the last 20 years"],"prefix":"10.1093","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9129-9519","authenticated-orcid":false,"given":"Alberto","family":"Aimo","sequence":"first","affiliation":[{"name":"Interdisciplinary Center for Health Sciences, Scuola Superiore Sant\u2019Anna , piazza Martiri della Libert\u00e0 33, 56127 Pisa ,","place":["Italy"]},{"name":"Cardiology Division, Fondazione Toscana Gabriele Monasterio , via Moruzzi 1, 56124 Pisa ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giorgia","family":"Panichella","sequence":"additional","affiliation":[{"name":"Careggi University Hospital Cardiology Department, , Largo G.A. 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