NCT07572032 Delayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected Aetiology (DELAY-HF), Pilot Study
| NCT ID | NCT07572032 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Kyungsub Song |
| Condition | Heart Failure Due to Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-05-20 |
| Primary Completion | 2028-05-20 |
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 2026-05-20 with a primary completion date of 2028-05-20.
⚠ 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
In patients with heart failure due to a reversible underlying cause-such as valvular heart disease or coronary artery disease-surgical or procedural correction of the underlying lesion (valve repair/replacement, TAVI, PCI, or CABG) frequently leads to spontaneous recovery of cardiac function, even without neurohormonal modulators. In this clinical setting, a substantial proportion of patients may not require the full set of guideline-directed medical therapies routinely prescribed for chronic HFrEF. The purpose of this study is to determine whether ARNI (angiotensin receptor-neprilysin inhibitor) and SGLT2 inhibitors are truly necessary in patients whose left ventricular function recovers spontaneously after treatment of a correctable cause of heart failure. The DELAY-HF trial (DELayed initiation of ARNI and SGLT2i in heart failure with corrected aetiologY) is a multicentre, randomised, open-label pilot trial with blinded end-point assessment (PROBE design) evaluating the safety and feasibility of a delayed-initiation strategy of ARNI and SGLT2i, compared with immediate initiation, in patients with heart failure whose underlying cause has been completely corrected by surgical or procedural intervention. A total of 80 patients (40 per arm) will be enrolled at four centres in South Korea. Adults with a preoperative left ventricular ejection fraction (LVEF) ≤40% who have undergone successful correction of a reversible cause of heart failure-either revascularization (PCI or CABG) for ischemic cardiomyopathy or valvular surgery (including TAVI) for left-sided valvular heart disease causing volume overload-will be randomized 1:1 to (1) delayed initiation, in which ARNI/SGLT2i are withheld for 6 months and started only in patients whose LVEF remains ≤40% at the 6-month assessment, versus (2) immediate guideline-directed medical therapy (GDMT) including ARNI/SGLT2i started shortly after the corrective procedure. All patients are followed for 12 months. The primary outcome is the absolute change in LVEF from baseline to 12 months. The between-group difference (delayed minus immediate) will be reported as a point estimate with a two-sided 95% confidence interval and evaluated against a pre-specified decision criterion (lower confidence limit above -5 percentage points). As a pilot trial, DELAY-HF is not powered for a confirmatory non-inferiority test; it aims to estimate the standard deviation of the primary outcome, recruitment and dropout rates, the rescue-therapy rate and safety data needed to design a subsequent confirmatory trial. Key secondary outcomes include cardiovascular and all-cause mortality, heart failure hospitalisation, additional echocardiographic indices, NT-proBNP, KCCQ-12 score, 6-minute walk distance, feasibility metrics, and a cost-effectiveness analysis. By comparing these two strategies, this pilot trial will provide preliminary estimates of the incremental contribution of ARNI and SGLT2i-to further LVEF recovery and to clinical outcomes-in patients who have already demonstrated spontaneous improvement in cardiac function after correction of the underlying cause, and will inform the design of a subsequent confirmatory trial addressing whether these agents are truly necessary in this population.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years. * Preoperative left ventricular ejection fraction (LVEF) ≤ 40% on echocardiography. * Successful surgical or procedural correction of a correctable underlying cause of heart failure: Valvular heart disease: mitral valve surgery, aortic valve surgery, transcatheter aortic valve implantation (TAVI), or tricuspid valve surgery, OR Ischemic cardiomyopathy: complete revascularization by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). * Enrollment between 3 months before and 10 days after the corrective procedure. * Hemodynamically stable post-operative state with NYHA class I, defined at the time of randomization as: Systolic blood pressure ≥ 90 mmHg sustained for at least 6 hours; No up-titration of intravenous diuretics within the preceding 6 hours; No use of intravenous vasodilators within the preceding 6 hours; No use of intravenous inotropes within the preceding 24 hours; Heart rate 50-110 bpm and no clinical signs of volume overload. * Patients receiving ARNI or SGLT2 inhibitors prior to enrollment must complete a 1-week washout period before randomization. Provision of written informed consent. Exclusion Criteria: * Prior history of sustained ventricular tachycardia or ventricular fibrillation. * Greater-than-moderate paravalvular leak or residual mitral regurgitation after aortic or mitral valve surgery. * Incomplete revascularization in patients with coronary artery disease (residual significant disease in any major coronary territory: LAD, LCX, or RCA). * Graft occlusion documented on coronary CT angiography after CABG. Planned pregnancy during the study period. * Uncontrolled hypertension on medical therapy (systolic blood pressure \> 160 mmHg). * Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m². * Inability to tolerate ARNI, defined as inability to take sacubitril/valsartan 25 mg twice daily (e.g., due to symptomatic hypotension, history of angioedema, or bilateral renal artery stenosis). * Inability to tolerate SGLT2 inhibitors (e.g., type 1 diabetes mellitus or history of recurrent diabetic ketoacidosis). * Any other condition that, in the opinion of the investigator, would interfere with study participation or follow-up.
Contact & Investigator
Kyungsub Song, MD
STUDY DIRECTOR
Keimyung University Dongsan Medical Center
Frequently Asked Questions
Who can join the NCT07572032 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure Due to Coronary Artery Disease. 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 NCT07572032 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 NCT07572032 currently recruiting?
Yes, NCT07572032 is actively recruiting participants. Contact the research team at chest.songks@gmail.com for enrollment information.
Where is the NCT07572032 trial being conducted?
This trial is being conducted at Daegu, South Korea, Seongnam-si, South Korea, Suwon, South Korea, Seoul, South Korea.
Who is sponsoring the NCT07572032 clinical trial?
NCT07572032 is sponsored by Kyungsub Song. The principal investigator is Kyungsub Song, MD at Keimyung University Dongsan Medical Center. The trial plans to enroll 80 participants.
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