[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416528":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":126,"collaborators":25,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":130,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":25,"studyType":142,"phases":143,"briefSummary":146,"conditions":147,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Sardocor Corp.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SRD-001","EXPERIMENTAL","3E13 or 4.5E13 vg; one-time intracoronary infusion",[13],"Biological: SRD-001",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","One-time intracoronary infusion",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","AAV1\u002FSERCA2a",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"DRUG","SRD-001 matching placebo",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"COO","CONTACT","858-752-2941","info@sardocorcorp.com",[37,59,75,92,109],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"San Diego Cardiac Center","RECRUITING","San Diego","California","92123","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-117.16472,32.71571,{"lat":49,"lon":48},[52,56],{"name":53,"role":33,"phone":54,"phoneExt":25,"email":55},"Emma Burkhalter, RN","858-244-6890","eburkhalter@sdcardiac.com",{"name":57,"role":58,"phone":25,"phoneExt":25,"email":25},"Brian Jaski, MD","PRINCIPAL_INVESTIGATOR",{"facility":60,"status":39,"city":61,"state":41,"zip":62,"country":43,"countryCode":44,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"University of California, San Francisco","San Francisco","94143",{"type":46,"coordinates":64},[65,66],-122.41942,37.77493,{"lat":66,"lon":65},[69,73],{"name":70,"role":33,"phone":71,"phoneExt":25,"email":72},"Kaye Reambonanza","415-514-6147","Kaye.Reambonanza@ucsf.edu",{"name":74,"role":58,"phone":25,"phoneExt":25,"email":25},"Richard Cheng, MD",{"facility":76,"status":39,"city":77,"state":78,"zip":79,"country":43,"countryCode":44,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Washington University in Saint Louis","St Louis","Missouri","63110",{"type":46,"coordinates":81},[82,83],-90.19789,38.62727,{"lat":83,"lon":82},[86,90],{"name":87,"role":33,"phone":88,"phoneExt":25,"email":89},"Annie Dirks, RN, BSN","314-454-8711","aplatts@wustl.edu",{"name":91,"role":58,"phone":25,"phoneExt":25,"email":25},"Gregory Ewald, MD",{"facility":93,"status":39,"city":94,"state":95,"zip":96,"country":43,"countryCode":44,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"University of Texas Southwestern Medical Center","Dallas","Texas","75390",{"type":46,"coordinates":98},[99,100],-96.80667,32.78306,{"lat":100,"lon":99},[103,107],{"name":104,"role":33,"phone":105,"phoneExt":25,"email":106},"Therese Villina, MPHI, BSN","214-645-7083","Therese.Vallina@utsouthwestern.edu",{"name":108,"role":58,"phone":25,"phoneExt":25,"email":25},"Justin Grodin, MD",{"facility":110,"status":39,"city":111,"state":112,"zip":113,"country":43,"countryCode":44,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"University of Washington Medicine","Seattle","Washington","98195",{"type":46,"coordinates":115},[116,117],-122.33207,47.60621,{"lat":117,"lon":116},[120,124],{"name":121,"role":33,"phone":122,"phoneExt":25,"email":123},"Katherine Nassans","206-543-6850","Knassans@uw.edu",{"name":125,"role":58,"phone":25,"phoneExt":25,"email":25},"Kenta Nakamura, MD",{"type":127,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100416528","phase-1-modulation-of-serca2a-of-intra-myocytic-calcium-trafficking-in-heart-failure-with-reduced-ejection-fraction-100416528",false,"NCT04703842","Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction","A Phase 1\u002F2 Trial of the Safety and Efficacy of SRD-001 (AAV1\u002FSERCA2a) in Subjects With Heart Failure With Reduced Ejection Fraction","MUSIC-HFrEF1","Main Inclusion Criteria:\n\n* Chronic ischemic or non-ischemic cardiomyopathy\n* NYHA class III\u002FIV\n* LVEF ≤35%\n* Guideline-directed medical therapy for heart failure; ICD\n\nMain Exclusion Criteria:\n\n* Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm\n* Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), mechanical circulatory support device (MCSD) or cardiac shunt\n* Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6 months following treatment\n* Likely need for an immediate heart transplant or MCSD implant due to hemodynamic instability\n* Inadequate hepatic and renal function\n* Diagnosis of, or treatment for, any cancer within the last 5 years except for basal cell carcinoma or carcinomas in situ where surgical excision was considered curative","ALL","18 Years","80 Years",{"count":140,"type":141},57,"ESTIMATED","INTERVENTIONAL",[144,145],"PHASE1","PHASE2","It is believed that targeted SERCA2a enzyme replacement in HFrEF patients will correct defective intracellular Ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. Additionally, it is hypothesized that correcting SERCA2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.",[148,149,150,151],"Congestive Heart Failure","Heart Failure, Systolic","Heart Failure","HFrEF - Heart Failure With Reduced Ejection Fraction","2024-03-24",{"date":154,"type":155},"2024-03-26","ACTUAL",{"date":157,"type":155},"2021-09-23",{"date":159,"type":141},"2028-12",{"name":5,"class":6},5]