{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:24:06Z","timestamp":1792797846047,"version":"4.5.0"},"reference-count":37,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"7","license":[{"start":{"date-parts":[[2024,7,1]],"date-time":"2024-07-01T00:00:00Z","timestamp":1719792000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Heart Failure"],"published-print":{"date-parts":[[2024,7]]},"abstract":"\n BACKGROUND:<\/jats:title>\n \n LMNA<\/jats:italic>\n (\n lamin A\/C<\/jats:italic>\n )-related dilated cardiomyopathy is a rare genetic cause of heart failure. In a phase 2 trial and long-term extension, the selective p38\u03b1 MAPK (mitogen-activated protein kinase) inhibitor, ARRY-371797 (PF-07265803), was associated with an improved 6-minute walk test at 12 weeks, which was preserved over 144 weeks.\n <\/jats:p>\n <\/jats:sec>\n \n METHODS:<\/jats:title>\n \n REALM-DCM (NCT03439514) was a phase 3, randomized, double-blind, placebo-controlled trial in patients with symptomatic\n LMNA<\/jats:italic>\n -related dilated cardiomyopathy. Patients with confirmed\n LMNA<\/jats:italic>\n variants, New York Heart Association class II\/III symptoms, left ventricular ejection fraction \u226450%, implanted cardioverter-defibrillator, and reduced 6-minute walk test distance were randomized to ARRY-371797 400 mg twice daily or placebo. The primary outcome was a change from baseline at week 24 in the 6-minute walk test distance using stratified Hodges-Lehmann estimation and the van Elteren test. Secondary outcomes using similar methodology included change from baseline at week 24 in the Kansas City Cardiomyopathy Questionnaire-physical limitation and total symptom scores, and NT-proBNP (N-terminal pro-B-type natriuretic peptide) concentration. Time to a composite outcome of worsening heart failure or all-cause mortality and overall survival were evaluated using Kaplan-Meier and Cox proportional hazards analyses.\n <\/jats:p>\n <\/jats:sec>\n \n RESULTS:<\/jats:title>\n \n REALM-DCM was terminated after a planned interim analysis suggested futility. Between April 2018 and October 2022, 77 patients (aged 23\u201372 years) received ARRY-371797 (n=40) or placebo (n=37). No significant differences (\n P<\/jats:italic>\n >0.05) between groups were observed in the change from baseline at week 24 for all outcomes: 6-minute walk test distance (median difference, 4.9 m [95% CI, \u221224.2 to 34.1];\n P<\/jats:italic>\n =0.82); Kansas City Cardiomyopathy Questionnaire-physical limitation score (2.4 [95% CI, \u22126.4 to 11.2];\n P<\/jats:italic>\n =0.54); Kansas City Cardiomyopathy Questionnaire-total symptom score (5.3 [95% CI, \u22124.3 to 14.9];\n P<\/jats:italic>\n =0.48); and NT-proBNP concentration (\u2212339.4 pg\/mL [95% CI, \u22121131.6 to 452.7];\n P<\/jats:italic>\n =0.17). The composite outcome of worsening heart failure or all-cause mortality (hazard ratio, 0.43 [95% CI, 0.11\u20131.74];\n P<\/jats:italic>\n =0.23) and overall survival (hazard ratio, 1.19 [95% CI, 0.23\u20136.02];\n P<\/jats:italic>\n =0.84) were similar between groups. No new safety findings were observed.\n <\/jats:p>\n <\/jats:sec>\n \n CONCLUSIONS:<\/jats:title>\n \n Findings from REALM-DCM demonstrated futility without safety concerns. An unmet treatment need remains among patients with\n LMNA<\/jats:italic>\n -related dilated cardiomyopathy.\n <\/jats:p>\n <\/jats:sec>\n \n REGISTRATION:<\/jats:title>\n \n URL:\n https:\/\/classic.clinicaltrials.gov<\/jats:ext-link>\n ; Unique Identifiers: NCT03439514, NCT02057341, and NCT02351856.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1161\/circheartfailure.123.011548","type":"journal-article","created":{"date-parts":[[2024,7,9]],"date-time":"2024-07-09T09:01:15Z","timestamp":1720515675000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":29,"title":["REALM-DCM: A Phase 3, Multinational, Randomized, Placebo-Controlled Trial of ARRY-371797 in Patients With Symptomatic\n LMNA<\/i>\n -Related Dilated Cardiomyopathy"],"prefix":"10.1161","volume":"17","clinical-trial-number":[{"clinical-trial-number":"nct02351856","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03439514","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02057341","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5470-2257","authenticated-orcid":true,"given":"Pablo","family":"Garcia-Pavia","sequence":"first","affiliation":[{"name":"Hospital Universitario Puerta de Hierro Majadahonda, CIBERCV, IDIPHISA, Universidad Francisco de Vitoria and Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain (P.G.-P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose Fernando Rodriguez","family":"Palomares","sequence":"additional","affiliation":[{"name":"Servicio de Cardiolog\u00eda, Hospital Universitario Vall Hebr\u00f3n, Institut de Recerca Hospital Vall Hebr\u00f3n, Universitat Aut\u00f2noma de Barcelona, 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