Stepwise withdrawal of ARNI and SGLT2i in HF with normalized ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized trial compares a stepwise withdrawal of ARNI and SGLT2i to continuing guideline‑directed medical therapy in adults with HF with improved ejection fraction (HFimpEF) after surgical or catheter-based correction of a reversible cause. Participants must have LVEF recovered to ≥50% and NT-proBNP ≤250 ng/L, and must be on both medications for at least 3 months. The primary outcome is change in LVEF at 12 months, with non‑inferiority judged by a ≤5 percentage point difference versus continued therapy. The study aims to assess safety, feasibility, and to estimate event rates to inform a future larger trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Keimyung University Dongsan Hospital
  Daegu, Daegu, South Korea Recruiting
• Seoul National University Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Not yet recruiting
• Ajou University Hospital
  Suwon, Gyeonggi-do, South Korea Not yet recruiting
• Pusan National University Yangsan Hospital
  Yangsan, Gyeongsangnam-do, South Korea Not yet recruiting
• Korea University Anam Hospital
  Seoul, Seoul, South Korea Not yet recruiting

Study contacts

• Principal investigator: Hyung Gon Je, Professor — Seoul National University Bundang Hospital
• Study coordinator: Kyungsub Song, Professor
• Email: chest.songks@gmail.com
• Phone: 82)1065564907

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.