[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kyungsub Song\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100639301","phase-4-stepwise-de-escalation-and-optimizing-withdrawal-of-arni-and-sglt2i-in-normalized-heart-failure-100639301",false,"NCT07631156","STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure","STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure (STEP-DOWN HF Trial)","STEP-DOWN HF","Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Prior left ventricular ejection fraction (LVEF) ≤40% before surgery or intervention, with recovery to ≥50% (normalized range) at the time of enrollment\n* N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\\u003C250 ng\u002FL\n* Complete correction of a reversible underlying cause of heart failure: surgical or transcatheter correction of valvular heart disease (mitral regurgitation, aortic stenosis, aortic regurgitation), or percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for ischemic cardiomyopathy\n* Currently receiving both ARNI and SGLT2i for at least 3 months at enrollment (MRA and\u002For beta-blocker may also be used)\n* Clinically stable outpatient with no heart failure-related hospitalization within the prior 6 months\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Heart failure due to irreversible etiology (e.g., idiopathic dilated cardiomyopathy, toxic cardiomyopathy, genetic cardiomyopathy)\n* For valvular disease: moderate or greater paravalvular leak, or residual moderate or greater mitral or aortic regurgitation\n* For ischemic disease: incomplete revascularization or graft occlusion on post-operative coronary CT\n* Chronic kidney disease stage 4 or higher (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n* Symptomatic hypotension (systolic blood pressure \\\u003C90 mmHg) or symptomatic bradycardia (heart rate \\\u003C50 beats\u002Fmin)\n* Pregnant, suspected pregnancy, or breastfeeding\n* Terminal malignancy or end-stage organ failure with life expectancy \\\u003C12 months\n* Participation in another clinical trial within 3 months prior to screening\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for the study","ALL","19 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a multicenter, randomized, open-label pilot study to evaluate whether stepwise withdrawal of two heart failure medications-angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitor (SGLT2i)-is safe in patients with Heart Failure with improved Ejection Fraction (HFimpEF) whose underlying structural cause (valvular heart disease or ischemic cardiomyopathy) has been completely corrected by surgery or intervention.\n\nEighty adult patients (40 per arm) whose left ventricular ejection fraction (LVEF) has recovered to 50% or higher and whose NT-proBNP is ≤ 250 ng\u002FL will be randomized 1:1 to either (1) stepwise withdrawal of ARNI followed by SGLT2i over one month under close echocardiographic monitoring, or (2) continuation of their current guideline-directed medical therapy.\n\nThe primary outcome is the change in LVEF at 12 months, with non-inferiority of the withdrawal strategy declared if the LVEF decline is within 5 percentage points of the continuation arm. Secondary outcomes include cardiovascular death, heart failure hospitalization, NT-proBNP, quality of life (KCCQ-12), 6-minute walk distance, and adverse events.\n\nResults from this pilot will inform the design and sample size of a subsequent definitive non-inferiority trial and may provide initial evidence to guide deprescribing decisions in clinical practice.",[27,28,29],"Heart Failure With Reduced Ejection Fraction","Heart Failure","Ventricular Dysfunction, Left",[31,32,33,34,35,36,37,38],"HFimpEF","ARNI","Sacubitril\u002FValsartan","SGLT2 Inhibitor","Guideline-Directed Medical Therapy","Reverse Remodeling","Valvular Heart Disease","Ischemic Cardiomyopathy","NOT_YET_RECRUITING","2026-06-21",{"date":42,"type":43},"2026-06-24","ACTUAL",{"date":45,"type":21},"2026-06-30",{"date":47,"type":21},"2029-12-30",{"name":49,"class":50},"Kyungsub Song","OTHER",5,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100636926","phase-4-delayed-initiation-of-arni-and-sglt2i-in-heart-failure-with-corrected-aetiology-delay-hf-pilot-study-100636926","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.","18 Years",{"count":20,"type":21},[24],"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.",[64,65,28],"Heart Failure Due to Coronary Artery Disease","Valvular Cardiomyopathy",[67,68,69,70,71,72],"Heart failure","Recovered ejection fraction","ARNI (Angiotensin receptor-neprilysin inhibitor)","SGLT2 inhibitor","Valvular heart disease","Ischemic cardiomyopathy","RECRUITING","2026-05-27",{"date":76,"type":43},"2026-06-01",{"date":78,"type":43},"2026-05-20",{"date":80,"type":21},"2028-12-20",{"name":49,"class":50},4,""]