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Pharmaceuticals","STUDY_DIRECTOR",[42,46],{"name":39,"role":43,"phone":44,"phoneExt":29,"email":45},"CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":39,"role":43,"phone":47,"phoneExt":29,"email":29},"+41613241111",[49,70,86],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Synergy Healthcare","RECRUITING","Bradenton","Florida","34208","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-82.57482,27.49893,{"lat":61,"lon":60},[64,67],{"name":65,"role":43,"phone":29,"phoneExt":29,"email":66},"Shannon Stickels","sstickels@synergyhealthcorp.com",{"name":68,"role":69,"phone":29,"phoneExt":29,"email":29},"Patrick Weston","PRINCIPAL_INVESTIGATOR",{"facility":71,"status":51,"city":72,"state":53,"zip":73,"country":55,"countryCode":56,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Nature Coast Clinical Research LLC","Inverness","34452",{"type":58,"coordinates":75},[76,77],-82.33037,28.83582,{"lat":77,"lon":76},[80,84],{"name":81,"role":43,"phone":82,"phoneExt":29,"email":83},"Jill Barnett","+1 352 341 2100","jbarnett@flourishresearch.com",{"name":85,"role":69,"phone":29,"phoneExt":29,"email":29},"Rafik Abadier",{"facility":87,"status":51,"city":88,"state":53,"zip":89,"country":55,"countryCode":56,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Jacksonville Center for Clinical","Jacksonville","32216",{"type":58,"coordinates":91},[92,93],-81.65565,30.33218,{"lat":93,"lon":92},[96,100],{"name":97,"role":43,"phone":98,"phoneExt":29,"email":99},"Sara Villotti","+1 904 730 0101","svillotti@encoredocs.com",{"name":101,"role":69,"phone":29,"phoneExt":29,"email":29},"Michael J Koren",{"type":103,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100628746","phase-1-a-safety-and-tolerability-study-of-hjb647-in-heart-failure-participants-with-reduced-ejection-fraction-100628746",false,"NCT07465653","A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction","A Multi-center, Randomized, Participant- and Investigator- Blinded, Placebo-controlled Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of HJB647 in Participants With Chronic Stable Heart Failure With Reduced Ejection Fraction","Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria:\n\n* Men and women aged 18 years or older\n* Stable NYHA functional class II-III\n* LVEF \\\u003C50%\n* NT-proBNP ≥600 pg\u002Fml if in sinus rhythm or ≥900 pg\u002Fml if in atrial fibrillation at screening\n* On stable standard of care therapy with sacubitril\u002Fvalsartan with a dose of at least 49\u002F51 mg BID for at least 4 weeks before screening.\n\nExclusion Criteria:\n\nParticipants will be deemed ineligible for inclusion if they meet any of the following exclusion criteria:\n\n* Acute decompensated heart failure within 3 months prior to screening\n* SBP \\\u003C105 mmHg at screening or baseline.\n* Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, PCI, or carotid angioplasty within the 6 months prior to screening\n* Hemodynamically significant mitral and\u002For aortic valve disease, or any prior valve replacement, except mitral regurgitation secondary to LV dilation at screening\n* eGFR \\\u003C45 ml\u002Fmin\u002F1.73m2 at screening, as measured by the CKD-EPI formula\n* BMI \\>40 kg\u002Fm2\n* Strong CYP3A4 inhibitors or inducers, sGC activators (vericiguat), PDE5 inhibitors, and nitroglycerin products\n* Women of childbearing potential\n\nFurther eligibility criteria might apply in alignment with the trial protocol.","ALL","18 Years","100 Years",{"count":115,"type":116},12,"ESTIMATED","INTERVENTIONAL",[119],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of HJB647 at two different doses in participants with chronic stable heart failure with reduced or mildly reduced ejection fraction (HFrEF\u002FHFmrEF).",[122],"Heart Failure With Reduced Ejection Fraction",[124,125,126,127,128,129],"Sacubitril","Valsartan","Heart failure","Cardiac Failure","Myocardial Failure","Heart failure with reduced ejection fraction","2026-04-10",{"date":132,"type":133},"2026-04-15","ACTUAL",{"date":135,"type":133},"2026-03-18",{"date":137,"type":116},"2026-09-24",{"name":39,"class":6},3]