[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Affinia Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100625729","phase-1-an-aav-gene-therapy-trial-of-aftx-201-in-adults-with-bag3-associated-dilated-cardiomyopathy-dcm-100625729",false,"NCT07426419","An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)","A Phase 1\u002F2 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Trial to Assess the Safety, Tolerability, Pharmacodynamics, and Preliminary Efficacy of AFTX-201 Administered to Adult Participants With BCL2-Associated Athanogene 3 (BAG3) Mutation-Associated Dilated Cardiomyopathy: UPBEAT Trial","UPBEAT","Inclusion Criteria:\n\nMale or female, 18 to 55 years of age\n\nTruncating mutation in BAG3\n\nDilated cardiomyopathy with left ventricular ejection fraction (LVEF) \\\u003C 45%\n\nNYHA Class II or III heart failure symptoms\n\nNT-proBNP ≥ 300 pg\u002FmL for subjects in sinus rhythm or paced rhythm, or ≥ 600 pg\u002FmL for subjects in atrial fibrillation\n\nWilling and able to sign informed consent and comply with study procedures\n\nExclusion Criteria:\n\nPrior myocardial infarction, heart transplant, or presence\u002Frequirement of a left ventricular assist device (LVAD)\n\nIV therapy with positive inotropes, vasodilators, or diuretics for heart failure within 30 days prior to enrollment\n\nPositive neutralizing antibodies to ATC-0187\n\nAny condition that, in the investigator's opinion, would place the subject at undue risk or interfere with study participation or interpretation of results","ALL","18 Years","55 Years",{"count":21,"type":22},22,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is a Phase 1\u002F2, open-label, dose-exploration and dose-expansion, clinical trial evaluating the safety, tolerability, pharmacodynamics, and preliminary efficacy of a single intravenous infusion of AFTX-201 in adults with dilated cardiomyopathy caused by a BAG3 gene mutation",[29,30],"Dilated Cardiomyopathy (DCM)","BAG3 Mutation Associated Dilated Cardiomyopathy",[32,33,34,35,36,37,38],"AFTX-201","Gene Therapy","AAV","BAG3","Dilated Cardiomyopathy","DCM","ATC-0187","RECRUITING","2026-06-30",{"date":42,"type":43},"2026-07-02","ACTUAL",{"date":45,"type":22},"2026-06",{"date":47,"type":22},"2032-12",{"name":49,"class":50},"Affinia Therapeutics","INDUSTRY",2,""]