{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,14]],"date-time":"2026-03-14T12:44:56Z","timestamp":1773492296076,"version":"3.50.1"},"reference-count":25,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2013,1,23]]},"abstract":"\n Background<\/jats:title>\n \n Primary\u2010prevention implantable cardioverter\u2010defibrillators (\n ICDs<\/jats:styled-content>\n ) reduce total mortality in patients with severe left ventricular systolic function. However, only a minority of patients benefit from these devices. We designed the Prospective Observational Study of Implantable Cardioverter\u2010Defibrillators (\n PROSE<\/jats:styled-content>\n \u2010\n ICD<\/jats:styled-content>\n ) to identify risk factors and enhance our understanding of the biological mechanisms that predispose to arrhythmic death in patients undergoing\n ICD<\/jats:styled-content>\n implantation for primary prevention of sudden death.\n <\/jats:p>\n <\/jats:sec>\n \n Methods and Results<\/jats:title>\n \n This is a multicenter prospective cohort study with a target enrollment of 1200 patients. The primary end point is\n ICD<\/jats:styled-content>\n shocks for adjudicated ventricular tachyarrhythmias. The secondary end point is total mortality. All patients undergo a comprehensive evaluation including history and physical examination, signal\u2010averaged electrocardiograms, and blood sampling for genomic, proteomic, and metabolomic analyses. Patients are evaluated every 6\u00a0months and after every known\n ICD<\/jats:styled-content>\n shock for additional electrocardiographic and blood sampling. As of December 2011, a total of 1177 patients have been enrolled with more nonwhite and female patients compared to previous randomized trials. A total of 143 patients have reached the primary end point, whereas a total of 260 patients died over an average follow\u2010up of 59\u00a0months. The\n PROSE<\/jats:styled-content>\n \u2010\n ICD<\/jats:styled-content>\n study represents a real\u2010world cohort of individuals with systolic heart failure receiving primary\u2010prevention\n ICDs<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Extensive electrophysiological and structural phenotyping as well as the availability of serial\n DNA<\/jats:styled-content>\n and serum samples will be important resources for evaluating novel metrics for risk stratification and identifying patients at risk for arrhythmic sudden death.\n <\/jats:p>\n <\/jats:sec>\n \n Clinical Trial Registration<\/jats:title>\n \n URL<\/jats:styled-content>\n :\n http:\/\/clinicaltrials.gov\/<\/jats:ext-link>\n Unique Identifier:\n NCT<\/jats:styled-content>\n 00733590.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1161\/jaha.112.000083","type":"journal-article","created":{"date-parts":[[2013,5,24]],"date-time":"2013-05-24T16:49:11Z","timestamp":1369414151000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":42,"title":["Prospective Observational Study of Implantable Cardioverter\u2010Defibrillators in Primary Prevention of Sudden Cardiac Death: Study Design and Cohort Description"],"prefix":"10.1161","volume":"2","author":[{"given":"Alan","family":"Cheng","sequence":"first","affiliation":[{"name":"Department of Medicine, Johns Hopkins University, Baltimore, MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Darshan","family":"Dalal","sequence":"additional","affiliation":[{"name":"Department of Medicine, Johns Hopkins University, Baltimore, MD"},{"name":"Department of Epidemiology, Johns Hopkins University, Baltimore, MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Butcher","sequence":"additional","affiliation":[{"name":"Department of Medicine, Johns Hopkins University, Baltimore, MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanaz","family":"Norgard","sequence":"additional","affiliation":[{"name":"Department of Medicine, Johns Hopkins University, Baltimore, MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yiyi","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Johns Hopkins University, Baltimore, MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timm","family":"Dickfeld","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Maryland, Baltimore, MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zayd A.","family":"Eldadah","sequence":"additional","affiliation":[{"name":"Washington Hospital Center, Washington, 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