{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T00:59:54Z","timestamp":1793408394739,"version":"4.5.0"},"reference-count":29,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"11","funder":[{"name":"Sanofi"},{"name":"Danish Cardiovascular Academy","award":["NNF20SA0067242"],"award-info":[{"award-number":["NNF20SA0067242"]}]}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Heart Failure"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>Influenza contributes substantially to disease burden in individuals with heart failure (HF) and is an established trigger of cardiovascular and HF events. Standard-dose inactivated influenza vaccine (SD-IIV) is recommended for HF, though immune responses may be attenuated. High-dose inactivated influenza vaccine (HD-IIV) was developed to enhance immunogenicity, but its effectiveness compared with SD-IIV against hospitalization for influenza and cardiovascular disease by HF status remains uncertain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>This was a prespecified analysis of a pragmatic, prospective, individually randomized, open-label trial with registry-based end point-evaluation conducted in Denmark across the 2022\/2023 to 2024\/2025 influenza seasons. Citizens \u226565 years were randomized 1:1 to HD-IIV or SD-IIV. Outcomes included hospitalization for influenza-related illness, laboratory-confirmed influenza, any cardiovascular disease, cardio-respiratory disease, and HF, assessed by HF status. Effect of HD-IIV versus SD-IIV in reducing risk of outcomes assessed was expressed as risk ratios.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      The trial randomized 332\u2009438 participants (48.6% female; mean age, 73.7\u00b15.8 years), including 10\u2009410 with HF at baseline (27.4% female; mean age, 76.0\u00b16.3 years). Overall, HD-IIV was associated with a statistically significant lower incidence of hospitalization for influenza-related illness, laboratory-confirmed influenza, cardio-respiratory disease, cardiovascular disease, and HF compared with SD-IIV. In participants with HF, effect estimates were similar: risk ratio for influenza-related hospitalization was 0.48 (95% CI, 0.20\u20131.06;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      <jats:sub>interaction<\/jats:sub>\n                      =0.64), for laboratory-confirmed influenza hospitalization 0.55 (95% CI, 0.29\u20131.02;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      <jats:sub>interaction<\/jats:sub>\n                      =0.59), for cardio-respiratory hospitalization 0.89 (95% CI, 0.77\u20131.02;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      <jats:sub>interaction<\/jats:sub>\n                      =0.34), for cardiovascular hospitalization 0.86 (95% CI, 0.72\u20131.02;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      <jats:sub>interaction<\/jats:sub>\n                      =0.34), and for HF hospitalization 0.82 (95% CI, 0.61\u20131.11;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      <jats:sub>interaction<\/jats:sub>\n                      =0.83). Findings were consistent across HF subgroups by disease duration, recency of hospitalization, most recent NT-proBNP (N-terminal pro-B-type natriuretic peptide), and presence of device therapy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>In this prespecified exploratory analysis of the largest individually randomized influenza vaccine trial ever conducted, HD-IIV was associated with lower rates of influenza and cardiovascular hospitalizations compared with SD-IIV, with effect estimates similar across HF status at baseline and HF subgroups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>REGISTRATION:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT05517174\">https:\/\/clinicaltrials.gov\/study\/NCT05517174<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circheartfailure.125.013678","type":"journal-article","created":{"date-parts":[[2025,8,30]],"date-time":"2025-08-30T12:00:11Z","timestamp":1756555211000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["High-Dose Versus Standard-Dose Influenza Vaccine in Heart Failure: A Prespecified Analysis of the DANFLU-2 Trial"],"prefix":"10.1161","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2690-7511","authenticated-orcid":true,"given":"Kristoffer Grundtvig","family":"Skaarup","sequence":"first","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6959-3236","authenticated-orcid":true,"given":"Niklas Dyrby","family":"Johansen","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7566-0519","authenticated-orcid":true,"given":"Daniel","family":"Modin","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew M.","family":"Loiacono","sequence":"additional","affiliation":[{"name":"Sanofi, Morristown, NJ (M.M.L.)."},{"name":"Department of Epidemiology, University of Delaware, Newark (M.M.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2636-1520","authenticated-orcid":true,"given":"Rebecca C.","family":"Harris","sequence":"additional","affiliation":[{"name":"Sanofi, Singapore (R.C.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-8389-4479","authenticated-orcid":true,"given":"Marine","family":"Dufournet","sequence":"additional","affiliation":[{"name":"Sanofi, Lyon, France (M. Dufournet)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carsten Schade","family":"Larsen","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, Department of Infectious Diseases, Aarhus University Hospital, Denmark (C.S.L.)."},{"name":"Danske L\u00e6gers Vaccinations Service\/European LifeCare Group, S\u00f8borg, Denmark (C.S.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4113-4182","authenticated-orcid":true,"given":"Lykke","family":"Larsen","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Odense University Hospital, Denmark (L.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2719-1743","authenticated-orcid":true,"given":"Lothar","family":"Wiese","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark (L.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3220-2526","authenticated-orcid":true,"given":"Michael","family":"Dalager-Pedersen","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Aalborg University Hospital, Denmark (M.D.-P.)."},{"name":"Department of Clinical Medicine, Aalborg University, Denmark (M.D.-P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4215-9218","authenticated-orcid":true,"given":"Brian L.","family":"Claggett","sequence":"additional","affiliation":[{"name":"Cardiovascular Division, Brigham and Women\u2019s Hospital, Harvard Medical School, Boston, MA (B.L.C., S.D.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katja Vu","family":"Bartholdy","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5324-9430","authenticated-orcid":true,"given":"Katrine Feldballe","family":"Bernholm","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie Inge-Marie Helene","family":"Borchsenius","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6642-416X","authenticated-orcid":true,"given":"Filip Soeskov","family":"Davidovski","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3584-6615","authenticated-orcid":true,"given":"Lise Witten","family":"Davodian","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Dons","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4110-3199","authenticated-orcid":true,"given":"Lisa Steen","family":"Duus","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2879-8862","authenticated-orcid":true,"given":"Caroline","family":"Espersen","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-8710-6945","authenticated-orcid":true,"given":"Frederik Holme","family":"Fussing","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3272-636X","authenticated-orcid":true,"given":"Anne Marie Reimer","family":"Jensen","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., G.H.G., T.B.-S.), Copenhagen University Hospital\u2014Herlev and Gentofte, Denmark."},{"name":"Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. Dons, L.S.D., C.E., F.H.F., A.M.R.J., N.E.L., A.C.F.L., M.C.H.L., A.B.N., C.I.O., M.S., T.B.-S.), Faculty of Health and Medical Sciences, University of Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nino Emanuel","family":"Landler","sequence":"additional","affiliation":[{"name":"Department of Cardiology (K.G.S., N.D.J., D.M., K.V.B., K.F.B., J.I.-M.H.B., F.S.D., L.W.D., M. 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