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Clinical Trials in South Korea / NCT07631156
Recruiting Phase 4

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

NCT07631156 · tracked via the Priya Life Science South Korea tracker
Sponsor
Kyungsub Song
Phase
Phase 4
Started
2026-08-12
Last updated
2026-09-02

Condition(s) studied

Heart Failure With Reduced Ejection FractionHeart FailureVentricular Dysfunction, Left

Investigational drug(s) / intervention(s)

Stepwise Withdrawal of ARNI and SGLT2iContinued Guideline-Directed Medical Therapy

Stepwise Withdrawal of ARNI and SGLT2i: 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: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Left Ventricular Ejection Fraction (LVEF) at 12 Months — Baseline to 12 months
    Absolute change (percentage points) in LVEF(%) from baseline to 12 months, measured by transthoracic echocardiography. Non-inferiority of stepwise withdrawal versus continuation is declared if the lower bound of the one-sided 95% confidence interval for the between-group difference exceeds -5 percentage points in the per-protocol population.

Trial sites (5)

FacilityCityRegionStatus
Keimyung University Dongsan Hospital Daegu Daegu Recruiting
Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Not Yet Recruiting
Ajou University Hospital Suwon Gyeonggi-do Not Yet Recruiting
Pusan National University Yangsan Hospital Yangsan Gyeongsangnam-do Not Yet Recruiting
Korea University Anam Hospital Seoul Seoul Not Yet Recruiting

More Kyungsub Song trials in South Korea

Delayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected Aetiology (DELAY-HF), Pilot Study Recruiting

Other trials for the same condition

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure Recruiting
Personalized Health Coaching for Patients With HF Recruiting
Delayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected Aetiology (DELAY-HF), Pilot Study Recruiting
Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07631156 on ClinicalTrials.gov ↗ ← All trials in South Korea