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RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Kyungsub Song • ClinicalTrials.gov ID: NCT07631156

Registry updated: 2026-09-02
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Description

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 ≤ 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 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. Results 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.

Interventions

  • Stepwise Withdrawal of ARNI and SGLT2i (Drug)
    Sequential discontinuation of angiotensin receptor-neprilysin inhibitor (ARNI; e.g., sacubitril/valsartan) and sodium-glucose cotransporter-2 inhibitor (SGLT2i; e.g., dapagliflozin or empagliflozin). ARNI is discontinued first; after a 1-month observation with echocardiographic and biomarker assessment, SGLT2i is discontinued if no signs of deterioration are observed. Concomitant MRA and beta-blocker therapy is continued.
  • Continued Guideline-Directed Medical Therapy (Drug)
    Continuation of currently prescribed ARNI and SGLT2i, together with any concomitant MRA and beta-blocker, at the doses being received at enrollment, per current guideline-directed medical therapy.

Eligibility criteria

Inclusion Criteria: * Adults aged 19 years or older * Prior left ventricular ejection fraction (LVEF) ≤40% before surgery or intervention, with recovery to ≥50% (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 m²) * 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

Conditions

Heart Failure With Reduced Ejection Fraction Heart Failure Ventricular Dysfunction, Left

Locations

  • Keimyung University Dongsan Hospital — Daegu, Daegu, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
  • Ajou University Hospital — Suwon, Gyeonggi-do, South Korea
  • Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, South Korea
  • Korea University Anam Hospital — Seoul, Seoul, South Korea
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record