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STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure

RecruitingPhase 4Ages 19 Years - anyAllKyungsub Song
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In plain words

What the trial is, and whether it could suit you

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. Eighty adult patients (40 per arm) whose left ventricular ejection fraction (LVEF) has recovered to 50% or higher and whose NT-proBNP is โ‰ค 250 ng/L 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. The primary outcome is the change in LVEF at 12 months, with non-inferiority

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults aged 19 years or older * Prior left ventricular ejection fraction (LVEF) โ‰ค40% before surgery or intervention, with recovery to โ‰ฅ50% (normalized range) at the time of enrollment * N-terminal pro-B-type natriuretic peptide (NT-proBNP) \<250 ng/L * 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 * Currently receiving both ARNI and SGLT2i for at least 3 months at enrollment (MRA and/or beta-blocker may also be used) * Clinically stable outpatient with no heart failure-related hospitalization within the prior 6 months * Able to provide written informed consent Exclusion Criteria: * Heart failure due to irreversible etiology (e.g., idiopathic dilated cardiomyopathy, toxic cardiomyopathy, genetic cardiomyopathy) * For valvular disease: moderate or greater paravalvular leak, or residual moderate or greater mitral or aortic regurgitation * For ischemic disease: incomplete revascularization or graft occlusion on post-operative coronary CT * Chronic kidney disease stage 4 or higher (eGFR \<30 mL/min/1.73 mยฒ) * Symptomatic hypotension (systolic blood pressure \<90 mmHg) or symptomatic bradycardia (heart rate \<50 beats/min) * Pregnant, suspected pregnancy, or breastfeeding * Terminal malignancy or end-stage organ failure with life expectancy \<12 months * Participation in another clinical trial within 3 months prior to screening * Any condition that, in the investigator's judgment, makes the participant unsuitable for the study
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What it tests

  • Stepwise Withdrawal of ARNI and SGLT2i
  • Continued Guideline-Directed Medical Therapy
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Where

5 sites
Keimyung University Dongsan Hospital
Daegu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Ajou University Hospital
Suwon, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Korea University Anam Hospital
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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