{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,10]],"date-time":"2026-11-10T19:56:24Z","timestamp":1794340584472,"version":"4.9.0"},"reference-count":17,"publisher":"American Medical Association (AMA)","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Cardiol"],"published-print":{"date-parts":[[2024,11,1]]},"abstract":"\n Importance<\/jats:title>\n Impaired exercise capacity is a cardinal manifestation of obstructive hypertrophic cardiomyopathy (HCM). The Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic Obstructive HCM (SEQUOIA-HCM) is a pivotal study characterizing the treatment effect of aficamten, a next-in-class cardiac myosin inhibitor, on a comprehensive set of exercise performance and clinical measures.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the effect of aficamten on exercise performance using cardiopulmonary exercise testing with a novel integrated measure of maximal and submaximal exercise performance and evaluate other exercise measures and clinical correlates.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n \n This was a prespecified analysis from SEQUOIA-HCM, a double-blind, placebo-controlled, randomized clinical trial. Patients were recruited from 101 sites in 14 countries (North America, Europe, Israel, and China). Individuals with symptomatic obstructive HCM with objective exertional intolerance (peak oxygen uptake [pVO\n 2<\/jats:sub>\n ] \u226490% predicted) were included in the analysis. Data were analyzed from January to March 2024.\n <\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Randomized 1:1 to aficamten (5-20 mg daily) or matching placebo for 24 weeks.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n \n The primary outcome was change from baseline to week 24 in integrated exercise performance, defined as the 2-component\n z<\/jats:italic>\n score of pVO\n 2<\/jats:sub>\n and ventilatory efficiency throughout exercise (minute ventilation [VE]\/carbon dioxide output [VCO\n 2<\/jats:sub>\n ] slope). Response rates for achieving clinically meaningful thresholds for change in pVO\n 2<\/jats:sub>\n and correlations with clinical measures of treatment effect (health status, echocardiographic\/cardiac biomarkers) were also assessed.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Among 282 randomized patients (mean [SD] age, 59.1\u2009[12.9] years; 115 female [40.8%], 167 male [59.2%]), 263 (93.3%) had core laboratory\u2013validated exercise testing at baseline and week 24. Integrated composite exercise performance improved in the aficamten group (mean [SD]\n z<\/jats:italic>\n score, 0.17\u2009[0.51]) from baseline to week 24, whereas the placebo group deteriorated (mean [SD]\n z<\/jats:italic>\n score, \u22120.19\u2009[0.45]), yielding a placebo-corrected improvement of 0.35 (95% CI, 0.25-0.46;\n P<\/jats:italic>\n \u2009&amp;lt;.001). Further, aficamten treatment demonstrated significant improvements in total workload, circulatory power, exercise duration, heart rate reserve, peak heart rate, ventilatory efficiency, ventilatory power, and anaerobic threshold (all\n P<\/jats:italic>\n &amp;lt;.001). In the aficamten group, large improvements (\u22653.0 mL\/kg per minute) in pVO\n 2<\/jats:sub>\n were more common than large reductions (32% and 2%, respectively) compared with placebo (16% and 11%, respectively). Improvements in both components of the primary outcome, pVO\n 2<\/jats:sub>\n and VE\/VCO\n 2<\/jats:sub>\n slope throughout exercise, were significantly correlated with improvements in symptom burden and hemodynamics (all\n P<\/jats:italic>\n &amp;lt;.05).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n This prespecified analysis of the SEQUOIA-HCM randomized clinical trial found that aficamten treatment improved a broad range of exercise performance measures. These findings offer valuable insight into the therapeutic effects of aficamten.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT05186818<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamacardio.2024.2781","type":"journal-article","created":{"date-parts":[[2024,9,4]],"date-time":"2024-09-04T11:06:07Z","timestamp":1725447967000},"page":"990","source":"Crossref","is-referenced-by-count":30,"title":["Aficamten and Cardiopulmonary Exercise Test Performance"],"prefix":"10.1001","volume":"9","author":[{"given":"Matthew M. 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