NCT07631156RecruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 1 Jun 2026
- Start date
- 12 Aug 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Kyungsub Song
- Diseases
- Heart failure
- NCT number
- NCT07631156
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- From 12 Aug 2026 to the primary completion date, 30 Jun 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial within 3 months prior to screening
Other illness
- 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
- Symptomatic hypotension (systolic blood pressure \<90 mmHg) or symptomatic bradycardia (heart rate \<50 beats/min)
- Terminal malignancy or end-stage organ failure with life expectancy \<12 months
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study
Lab values
- Chronic kidney disease stage 4 or higher (eGFR \<30 mL/min/1.73 m²)
Other
- Pregnant, suspected pregnancy, or breastfeeding
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Not yet recruiting |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Not yet recruiting |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.