NCT07631156 STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure
| NCT ID | NCT07631156 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Kyungsub Song |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-08-12 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2026-08-12 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Hyung Gon Je, Professor
PRINCIPAL INVESTIGATOR
Seoul National University Bundang Hospital
Frequently Asked Questions
Who can join the NCT07631156 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07631156 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07631156 currently recruiting?
Yes, NCT07631156 is actively recruiting participants. Contact the research team at chest.songks@gmail.com for enrollment information.
Where is the NCT07631156 trial being conducted?
This trial is being conducted at Daegu, South Korea, Seongnam-si, South Korea, Suwon, South Korea, Yangsan, South Korea and 1 additional location.
Who is sponsoring the NCT07631156 clinical trial?
NCT07631156 is sponsored by Kyungsub Song. The principal investigator is Hyung Gon Je, Professor at Seoul National University Bundang Hospital. The trial plans to enroll 80 participants.
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