[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636926":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":43,"locations":48,"responsibleParty":111,"collaborators":115,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":27,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":27,"enrollmentInfo":130,"targetDuration":27,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":51,"whyStopped":27,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Keimyung University Dongsan Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Delayed initiation of ARNI and SGLT2i","EXPERIMENTAL","After surgical or procedural correction of the underlying cause of heart failure (valvular surgery\u002FTAVI or PCI\u002FCABG), ARNI and SGLT2 inhibitors are withheld and patients are observed for 6 months on background therapy excluding ARNI\u002FSGLT2i. At the 6-month assessment, ARNI and SGLT2i are initiated only in patients whose LVEF remains ≤40%. Patients with LVEF \\>40% continue without ARNI\u002FSGLT2i under observation. If symptomatic heart failure worsening or a ≥10 percentage-point decrease in LVEF occurs during the observation period, full guideline-directed medical therapy including ARNI and SGLT2i is started immediately as rescue therapy. All participants are followed for 12 months from randomization.",[13,14],"Drug: Sacubitril \u002F Valsartan","Drug: SGLT-2 inhibitor",{"label":16,"type":17,"description":18,"interventionNames":19},"Immediate initiation of ARNI and SGLT2i (standard GDMT)","ACTIVE_COMPARATOR","After surgical or procedural correction of the underlying cause of heart failure (valvular surgery\u002FTAVI or PCI\u002FCABG), full guideline-directed medical therapy including ARNI and SGLT2 inhibitors is initiated and titrated to the maximally tolerated doses according to current heart failure guidelines, and continued throughout the follow-up period. All participants are followed for 12 months from randomization.",[13,20],"Drug: SGLT2 Inhibition",[22,28,32,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Sacubitril \u002F Valsartan","In the delayed-initiation arm, sacubitril\u002Fvalsartan is withheld for 6 months after the corrective procedure; valsartan is used for blood pressure control and background heart failure therapy. At the 6-month assessment, sacubitril\u002Fvalsartan is initiated only in patients with LVEF ≤40%. Patients with LVEF \\>40% continue their existing regimen without ARNI.\n\nIf heart failure worsens during observation (symptomatic deterioration or a ≥10 percentage-point drop in LVEF), sacubitril\u002Fvalsartan is started immediately as rescue therapy. Patients on ARNI prior to enrollment undergo a 1-week washout before randomization.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"SGLT-2 inhibitor","In the delayed-initiation arm, the SGLT2 inhibitor (dapagliflozin 10 mg once daily or empagliflozin 10 mg once daily) is withheld during the first 6 months and initiated at the 6-month assessment only in patients whose LVEF remains ≤40%; patients whose LVEF has recovered to \\>40% continue without SGLT2i under observation.\n\nIf heart failure worsens during the observation period, the SGLT2 inhibitor is started immediately as rescue therapy. Patients receiving SGLT2i prior to enrollment undergo a 1-week washout before randomization.",[9],{"type":23,"name":24,"description":33,"armGroupLabels":34,"otherNames":27},"In the immediate-initiation arm, sacubitril\u002Fvalsartan is started within 7 days after the corrective procedure, once the patient is hemodynamically stable and euvolemic. The starting dose is selected based on baseline blood pressure (25 mg to 200 mg twice daily) and titrated to the maximally tolerated dose (target 200 mg twice daily), continued throughout the 12-month follow-up.",[16],{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":27},"SGLT2 Inhibition","An SGLT2 inhibitor (dapagliflozin 10 mg once daily or empagliflozin 10 mg once daily, at the discretion of the treating physician) is used as one of the foundational therapies of guideline-directed medical therapy for heart failure. In the immediate-initiation arm, the SGLT2 inhibitor is started after correction of the underlying cause of heart failure and continued throughout the 12-month follow-up.",[16],[40],{"name":41,"affiliation":5,"role":42},"Kyungsub Song, MD","STUDY_DIRECTOR",[44],{"name":41,"role":45,"phone":46,"phoneExt":27,"email":47},"CONTACT","82)053-258-7307","chest.songks@gmail.com",[49,67,83,97],{"facility":50,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":27,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Keimyung University Dongsan Hospital","RECRUITING","Daegu","42601","South Korea",{"type":56,"coordinates":57},"Point",[58,59],128.59111,35.87028,{"lat":59,"lon":58},[62,64],{"name":41,"role":45,"phone":63,"phoneExt":27,"email":47},"+82-53-258-7307",{"name":65,"role":66,"phone":27,"phoneExt":27,"email":27},"In-Cheol Kim, MD\u002FPhD","SUB_INVESTIGATOR",{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":54,"countryCode":27,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Seoul National University Bundang Hospital","NOT_YET_RECRUITING","Seongnam-si","Gyeonggi-do","13620",{"type":56,"coordinates":74},[75,76],127.13778,37.43861,{"lat":76,"lon":75},[79],{"name":80,"role":45,"phone":81,"phoneExt":27,"email":82},"Hyung Gon Je, MD\u002FPhD","+82-31-787-7141","jehg7332@gmail.com",{"facility":84,"status":69,"city":85,"state":71,"zip":86,"country":54,"countryCode":27,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Ajou University Hospital","Suwon","16499",{"type":56,"coordinates":88},[89,90],127.00889,37.29111,{"lat":90,"lon":89},[93],{"name":94,"role":45,"phone":95,"phoneExt":27,"email":96},"Soo Jin Park, MD\u002FPhD","+82-31-219-5210","soojinima@gmail.com",{"facility":98,"status":69,"city":99,"state":99,"zip":100,"country":54,"countryCode":27,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Korea University Anam Hospital","Seoul","02841",{"type":56,"coordinates":102},[103,104],126.9784,37.566,{"lat":104,"lon":103},[107],{"name":108,"role":45,"phone":109,"phoneExt":27,"email":110},"Jun Ho Lee, MD\u002FPhD","+82-2-920-5369","ecmo1987@gmail.com",{"type":112,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Kyungsub Song","Assistant Professor, Department of Cardiovascular and Thoracic Surgery, Keimyung University Dongsan Hospital",[116,117,118],{"name":68,"class":6},{"name":98,"class":6},{"name":119,"class":120},"Ajou University Medical Center","UNKNOWN","100636926","phase-4-delayed-initiation-of-arni-and-sglt2i-in-heart-failure-with-corrected-aetiology-delay-hf-pilot-study-100636926",false,"NCT07572032","Delayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected Aetiology (DELAY-HF), Pilot Study","DELayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected aetiologY (DELAY-HF), Pilot Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Preoperative left ventricular ejection fraction (LVEF) ≤ 40% on echocardiography.\n* Successful surgical or procedural correction of a correctable underlying cause of heart failure: Valvular heart disease: mitral valve surgery, aortic valve surgery, transcatheter aortic valve implantation (TAVI), or tricuspid valve surgery, OR Ischemic cardiomyopathy: complete revascularization by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).\n* Enrollment between 3 months before and 10 days after the corrective procedure.\n* Hemodynamically stable post-operative state with NYHA class I, defined at the time of randomization as: Systolic blood pressure ≥ 100 mmHg sustained for at least 6 hours; No up-titration of intravenous diuretics within the preceding 6 hours; No use of intravenous vasodilators within the preceding 6 hours; No use of intravenous inotropes within the preceding 24 hours; Heart rate 50-110 bpm and no clinical signs of volume overload.\n* Patients receiving ARNI or SGLT2 inhibitors prior to enrollment must complete a 1-week washout period before randomization.\n\nProvision of written informed consent.\n\nExclusion Criteria:\n\n* Prior history of sustained ventricular tachycardia or ventricular fibrillation.\n* Greater-than-moderate paravalvular leak or residual mitral regurgitation after aortic or mitral valve surgery.\n* Incomplete revascularization in patients with coronary artery disease (residual significant disease in any major coronary territory: LAD, LCX, or RCA).\n* Graft occlusion documented on coronary CT angiography after CABG. Planned pregnancy during the study period.\n* Uncontrolled hypertension on medical therapy (systolic blood pressure \\> 160 mmHg).\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m².\n* Inability to tolerate ARNI, defined as inability to take sacubitril\u002Fvalsartan 25 mg twice daily (e.g., due to symptomatic hypotension, history of angioedema, or bilateral renal artery stenosis).\n* Inability to tolerate SGLT2 inhibitors (e.g., type 1 diabetes mellitus or history of recurrent diabetic ketoacidosis).\n* Any other condition that, in the opinion of the investigator, would interfere with study participation or follow-up.","ALL","18 Years",{"count":131,"type":132},80,"ESTIMATED","INTERVENTIONAL",[135],"PHASE4","In patients with heart failure due to a reversible underlying cause-such as valvular heart disease or coronary artery disease-surgical or procedural correction of the underlying lesion (valve repair\u002Freplacement, TAVI, PCI, or CABG) frequently leads to spontaneous recovery of cardiac function, even without neurohormonal modulators. In this clinical setting, a substantial proportion of patients may not require the full set of guideline-directed medical therapies routinely prescribed for chronic HFrEF. The purpose of this study is to determine whether ARNI (angiotensin receptor-neprilysin inhibitor) and SGLT2 inhibitors are truly necessary in patients whose left ventricular function recovers spontaneously after treatment of a correctable cause of heart failure.\n\nThe DELAY-HF trial (DELayed initiation of ARNI and SGLT2i in heart failure with corrected aetiologY) is a multi-center, randomized controlled non-inferiority trial evaluating whether a delayed-initiation strategy of ARNI and SGLT2i is non-inferior to immediate initiation in patients with heart failure whose underlying cause has been completely corrected by surgical or procedural intervention.\n\nAdults with a preoperative left ventricular ejection fraction (LVEF) ≤40% who have undergone successful correction of a reversible cause of heart failure-either revascularization (PCI or CABG) for ischemic cardiomyopathy or valvular surgery (including TAVI) for left-sided valvular heart disease causing volume overload-will be randomized 1:1 to (1) delayed initiation, in which ARNI\u002FSGLT2i are withheld for 6 months and started only in patients whose LVEF remains ≤40% at the 6-month assessment, versus (2) immediate guideline-directed medical therapy (GDMT) including ARNI\u002FSGLT2i started shortly after the corrective procedure. All patients are followed for 12 months.\n\nThe primary outcome is the absolute change in LVEF from baseline at 12 months. Key secondary outcomes include cardiovascular mortality, heart failure hospitalization, additional echocardiographic indices, NT-proBNP, KCCQ quality-of-life score, 6-minute walk distance, and a cost-effectiveness analysis.\n\nBy comparing these two strategies, this trial will clarify the incremental contribution of ARNI and SGLT2i-both to further LVEF recovery and to clinical outcomes-in patients who have already demonstrated spontaneous improvement in cardiac function after correction of the underlying cause, and will thereby help define whether these agents are truly necessary in this population.",[138,139,140],"Heart Failure Due to Coronary Artery Disease","Valvular Cardiomyopathy","Heart Failure",[142,143,144,145,146,147],"Heart failure","Recovered ejection fraction","ARNI (Angiotensin receptor-neprilysin inhibitor)","SGLT2 inhibitor","Valvular heart disease","Ischemic cardiomyopathy","2026-05-27",{"date":150,"type":151},"2026-06-01","ACTUAL",{"date":153,"type":151},"2026-05-20",{"date":155,"type":132},"2028-12-20",{"name":113,"class":6},4]