{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:09:08Z","timestamp":1786975748797,"version":"build-2736575974"},"reference-count":42,"publisher":"American Medical Association (AMA)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n The clinical benefit of opportunistic genomic screening for familial hypercholesterolemia (FH) has not been demonstrated in a randomized clinical trial (RCT).<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the impact of returning clinically confirmed FH-associated genetic results on low-density lipoprotein cholesterol (LDL-C) levels.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This RCT was performed within the Veterans Health Administration, a large national health care system, and linked to the Million Veteran Program (MVP), a research biobank. Participants were MVP enrollees suspected to have an FH-associated genetic variant, as identified in their research data. Recruitment occurred from February 27, 2020, to September 20, 2022, and 6-month follow-up was completed October 21, 2024.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Delivery of clinical genetic confirmation testing and telegenetic counseling at baseline (immediate results arm) vs after 6 months (delayed results arm).<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Change in LDL-C levels (primary outcome) and proportions with treatment intensification and achievement of LDL-C target levels at 6 months (secondary outcomes).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The trial randomized 112 participants across 28 US states (mean age, 65.9 [range, 36-91] years; 94 [83.9%] men). Baseline mean (SD) LDL-C level was 109.5 (55.5) mg\/dL, and 86 participants (76.8%) were already receiving therapy to lower lipid levels. At 6 months, the between-arm difference in LDL-C level reduction was \u221210.5 (95% CI, \u221221.9 to 1.0) mg\/dL (\n P<\/jats:italic>\n \u2009=\u2009.07; Cohen\n d<\/jats:italic>\n \u2009=\u20090.34). Bayesian analysis suggested a high probability of benefit but was exploratory. Treatment was intensified in 11 of 55 participants (20.0%) in the immediate results arm vs 5 of 57 (8.8%) in the delayed results arm (\n P<\/jats:italic>\n \u2009=\u2009.09). Fifteen participants (27.3%) in the immediate results arm vs 14 (24.6%) in the delayed results arm (\n P<\/jats:italic>\n \u2009=\u2009.74) achieved LDL-C target levels. Thirty of 49 participants (61.2%) in the immediate results arm who completed this information shared their genetic result with a total of 98 relatives.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this RCT, opportunistic genomic screening for FH plus telegenetic counseling did not result in a statistically significant improvement in LDL-C levels and clinical management; however, the findings suggest that there may be a small to moderate benefit favoring the immediate results arm. Further research should be conducted to confirm these findings, optimize implementation strategies, and assess the long-term effects on cardiovascular outcomes.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT04178122<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2025.49664","type":"journal-article","created":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T16:30:42Z","timestamp":1767976242000},"page":"e2549664","source":"Crossref","is-referenced-by-count":2,"title":["Opportunistic Genomic Screening for Familial Hypercholesterolemia to Improve Low-Density Lipoprotein Cholesterol"],"prefix":"10.1001","volume":"9","author":[{"given":"Jason L.","family":"Vassy","sequence":"first","affiliation":[{"name":"Veterans Affairs (VA) Boston Healthcare System, Boston, Massachusetts"},{"name":"Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles A.","family":"Brunette","sequence":"additional","affiliation":[{"name":"Veterans Affairs (VA) Boston Healthcare System, Boston, Massachusetts"},{"name":"Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Yi","sequence":"additional","affiliation":[{"name":"Veterans Affairs (VA) Boston Healthcare System, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Themistocles L.","family":"Assimes","sequence":"additional","affiliation":[{"name":"VA Palo Alto Healthcare System, Palo Alto, California"},{"name":"Department of Medicine, Stanford University School of Medicine, Stanford, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kurt D.","family":"Christensen","sequence":"additional","affiliation":[{"name":"Harvard Medical School, Boston, Massachusetts"},{"name":"Precision Medicine Translational Research Center, Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua W.","family":"Knowles","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Cardiovascular Institute, Department of Medicine, Stanford University School of Medicine, Stanford, California"},{"name":"Cardiovascular Institute, Department of Medicine, Stanford University School of Medicine, Stanford, California"},{"name":"Prevention Research Center, Stanford University School of Medicine, Stanford, California"},{"name":"Diabetes Research Center, Stanford University School of Medicine, Stanford, California"},{"name":"The Family Heart Foundation, Fernandina Beach, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy C.","family":"Sturm","sequence":"additional","affiliation":[{"name":"Ohio State Genomic Health, The Ohio State University Wexner Medical Center, Columbus, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan V.","family":"Sun","sequence":"additional","affiliation":[{"name":"Atlanta VA Healthcare System, Atlanta, Georgia"},{"name":"Department of Epidemiology and Global Health, Emory University Rollins School of Public Health"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Alexander","sequence":"additional","affiliation":[{"name":"Bucharest University for Economic Studies, Bucharest, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark P.","family":"Cardellino","sequence":"additional","affiliation":[{"name":"Veterans Affairs (VA) Boston Healthcare System, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia","family":"Harrison","sequence":"additional","affiliation":[{"name":"Veterans Affairs (VA) Boston Healthcare System, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haley L.","family":"Gerety","sequence":"additional","affiliation":[{"name":"Veterans Affairs (VA) Boston Healthcare System, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Pyatt","sequence":"additional","affiliation":[{"name":"Veterans Affairs (VA) Boston Healthcare System, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ron","family":"Vered","sequence":"additional","affiliation":[{"name":"Veterans Affairs (VA) Boston Healthcare System, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter W. 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