Heart Failure Due to Coronary Artery DiseasePhase 4NCT07572032
Delayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected Aetiology (DELAY-HF), Pilot Study
A Phase 4 study testing Sacubitril / Valsartan, SGLT-2 inhibitor and SGLT2 Inhibition in people with Heart Failure Due to Coronary Artery Disease and Valvular Cardiomyopathy, run by Kyungsub Song at 4 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Due to Coronary Artery Disease, Valvular Cardiomyopathy, Heart Failure
- What is being tested?
- Sacubitril / Valsartan, SGLT-2 inhibitor and SGLT2 Inhibition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 20 May 2026to 20 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Keimyung University Dongsan Hospital
Daegu, Daegu, 42601
Kyungsub Song, MD, +82-53-258-7307, chest.songks@gmail.com
In-Cheol Kim, MD/PhD
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Hyung Gon Je, MD/PhD, +82-31-787-7141, jehg7332@gmail.com
- Not yet recruiting
Korea University Anam Hospital
Seoul, Seoul, 02841
Jun Ho Lee, MD/PhD, +82-2-920-5369, ecmo1987@gmail.com
- Not yet recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Soo Jin Park, MD/PhD, +82-31-219-5210, soojinima@gmail.com
About this study
Official title: DELayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected aetiologY (DELAY-HF), Pilot Study
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.
Read more
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.
Read the detailed description
- Scientific Background and Rationale Contemporary heart failure (HF) guidelines recommend the early and simultaneous initiation of the four foundational pillars of guideline-directed medical therapy (GDMT)-ARNI (or ACEi/ARB), beta-blocker, mineralocorticoid receptor antagonist, and SGLT2 inhibitor-in patients with a reduced left ventricular ejection fraction (LVEF). The pivotal trials supporting these recommendations, however, were conducted predominantly in patients with chronic HFrEF in whom the underlying aetiology was either non-correctable or had not been definitively addressed. A clinically distinct population is encountered when the underlying cause of heart failure is fully reversible: patients with ischaemic cardiomyopathy who undergo complete revascularization, and patients with left-sided valvular disease causing chronic pressure or volume overload (severe aortic stenosis, aortic regurgitation, primary mitral regurgitation) who undergo valvular surgery or transcatheter intervention. In these patients, removal of the haemodynamic insult itself drives a substantial portion of subsequent LVEF recovery, independent of neurohormonal blockade. Consequently, universal and immediate initiation of ARNI and SGLT2i in this population may expose patients who would have recovered spontaneously to drug-related adverse effects (symptomatic hypotension, hyperkalaemia, renal dysfunction, genitourinary infection, ketoacidosis), to the burden of polypharmacy, and to avoidable cost, with uncertain incremental benefit on cardiac function or clinical outcome. The optimal timing of ARNI and SGLT2i initiation in patients whose underlying cause of HF has been definitively corrected has not been prospectively examined.
- Study Hypothesis The central hypothesis of DELAY-HF is that, in patients in whom the underlying cause of heart failure has been surgically or procedurally corrected, the LVEF recovery attributable to treatment of the underlying cause is substantially greater than the incremental recovery attributable to ARNI and SGLT2i. Under this hypothesis, the 12-month LVEF change in the delayed-initiation arm is expected to be no more than 5 percentage points worse than in the immediate-initiation arm. As a pilot trial, DELAY-HF estimates this difference with a 95% confidence interval and evaluates it against the pre-specified decision criterion; a formal non-inferiority hypothesis test will be performed in a subsequent, separately designed confirmatory trial.
- Pre-specified Analyses
Four pre-specified analyses are planned to fully characterise the contribution of ARNI/SGLT2i in this population:
- Effect of early ARNI/SGLT2i on LVEF recovery. Patients in the delayed-initiation arm who never received ARNI/SGLT2i during the 12-month follow-up (those without recovery at 6 months who were ultimately not started, plus those who recovered spontaneously) will be compared with the immediate-initiation arm to estimate the contribution of early ARNI/SGLT2i to LVEF recovery beyond the recovery driven by treatment of the underlying cause.
- Safety of delayed initiation. Within the delayed-initiation arm, patients who received delayed ARNI/SGLT2i and recovered will be compared with those who received delayed therapy without recovery, to evaluate whether postponing therapy by 6 months in non-recovering patients is associated with an attenuation of subsequent LVEF response.
- Twelve-month head-to-head comparison. The proportion of patients achieving LVEF recovery and the magnitude of LVEF improvement at the 12-month assessment will be compared directly between the delayed-initiation and immediate-initiation arms.
- Spontaneous versus pharmacologic recovery. Among patients in the delayed-initiation arm whose LVEF recovered spontaneously after correction of the underlying cause (without medication), the magnitude of LVEF recovery will be compared with that achieved in patients in the immediate-initiation arm whose recovery occurred while on ARNI/SGLT2i.
- Sample Size Justification Sample Size Justification. The sample size of 80 patients (40 per arm) was not derived from a power calculation for hypothesis testing, in keeping with the exploratory purpose of a pilot trial. It is based on: (1) the recommendation of Whitehead et al. (2016) of 25-40 participants per arm for a pilot trial preceding a main trial with a standardised effect size of 0.5 (decision margin Δ = 5 percentage points, assumed SD ≈ 10 percentage points); (2) consistency with prior randomised trials of GDMT withdrawal in recovered heart failure (ReReRe n = 80, TRED-HF n = 51, CATHEDRAL-HF n = 60); (3) detection of a safety signal-approximately 80% power (Fisher's exact test, α = 0.05) to detect a rescue-therapy rate of 25% in the delayed arm versus 5% in the immediate arm; (4) estimation of feasibility metrics (recruitment, adherence, 12-month follow-up completion) within a 95% confidence interval of approximately ±10 percentage points; and (5) an allowance of 10%
- Exploratory Analyses A pre-specified exploratory aim of the trial is to estimate the proportion of patients in the delayed-initiation arm in whom ARNI and SGLT2i can ultimately be deemed unnecessary-that is, those whose cardiac function has recovered sufficiently at 6 months that initiation is not warranted under the trial protocol. A formal cost-effectiveness analysis (incremental cost-effectiveness ratio) will compare the two strategies from the healthcare-system perspective.
- Expected Implications If the delayed-initiation strategy proves safe and feasible in this pilot, with no clinically important signal of harm on the LVEF decision criterion, the findings will support a subsequent confirmatory trial and, ultimately, a more individualised prescribing approach in patients with a corrected cause of heart failure-reserving ARNI and SGLT2i for those who fail to recover spontaneously-thereby reducing unnecessary drug exposure, adverse-effect burden, and cost in a population that is currently treated uniformly under generalised HFrEF guidelines.
- Safety Monitoring Safety Monitoring. An independent Data and Safety Monitoring Board (DSMB) will perform two interim safety reviews: after the first 40 patients complete 12-month follow-up and after enrolment of 80 patients. Safety data from the intensive 6-month observation period of the delayed-initiation arm (rescue-therapy rate, heart failure hospitalisation, death) will be reviewed separately by aetiology (valvular vs ischaemic). A rescue-therapy rate exceeding 20% in the delayed-initiation arm triggers a DSMB review, and stratum-specific discontinuation of enrolment may be recommended.
- Being tested
- Sacubitril / Valsartan, SGLT-2 inhibitor, SGLT2 Inhibition
- Keywords
- Heart failure, Recovered ejection fraction, ARNI (Angiotensin receptor-neprilysin inhibitor), SGLT2 inhibitor, Valvular heart disease, Ischemic cardiomyopathy
- Medical subject headings
- Heart Failure, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril / ValsartanDrug
In the delayed-initiation arm, sacubitril/valsartan is withheld for 6 months after the corrective procedure; valsartan is used for blood pressure control and background heart failure therapy. At the 6-month assessment, sacubitril/valsartan is initiated only in patients with LVEF ≤40%. Patients with LVEF >40% continue their existing regimen without ARNI.
If heart failure worsens during observation (symptomatic deterioration or a ≥10 percentage-point drop in LVEF), sacubitril/valsartan is started immediately as rescue therapy. Patients on ARNI prior to enrollment undergo a 1-week washout before randomization.
SGLT-2 inhibitorDrug
In the delayed-initiation arm, the SGLT2 inhibitor (dapagliflozin 10 mg once daily or empagliflozin 10 mg once daily) is withheld during the first 6 months and initiated at the 6-month assessment only in patients whose LVEF remains ≤40%; patients whose LVEF has recovered to >40% continue without SGLT2i under observation.
If heart failure worsens during the observation period, the SGLT2 inhibitor is started immediately as rescue therapy. Patients receiving SGLT2i prior to enrollment undergo a 1-week washout before randomization.
Sacubitril / ValsartanDrug
In the immediate-initiation arm, sacubitril/valsartan is started within 7 days after the corrective procedure, once the patient is hemodynamically stable and euvolemic. The starting dose is selected based on baseline blood pressure (25 mg to 200 mg twice daily) and titrated to the maximally tolerated dose (target 200 mg twice daily), continued throughout the 12-month follow-up.
SGLT2 InhibitionDrug
An SGLT2 inhibitor (dapagliflozin 10 mg once daily or empagliflozin 10 mg once daily, at the discretion of the treating physician) is used as one of the foundational therapies of guideline-directed medical therapy for heart failure. In the immediate-initiation arm, the SGLT2 inhibitor is started after correction of the underlying cause of heart failure and continued throughout the 12-month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Delayed initiation of ARNI and SGLT2i | Experimental | After surgical or procedural correction of the underlying cause of heart failure (valvular surgery/TAVI or PCI/CABG), ARNI and SGLT2 inhibitors are withheld and patients are observed for 6 months on background therapy excluding ARNI/SGLT2i. At the 6-month assessment, ARNI and SGLT2i are initiated only in patients whose LVEF remains ≤40%. Patients with LVEF >40% continue without ARNI/SGLT2i under observation. If symptomatic heart failure worsening or a ≥10 percentage-point decrease in LVEF occurs during the observation period, full guideline-directed medical therapy including ARNI and SGLT2i is started immediately as rescue therapy. All participants are followed for 12 months from randomization. Receives: Drug: Sacubitril / Valsartan; Drug: SGLT-2 inhibitor |
| Immediate initiation of ARNI and SGLT2i (standard GDMT) | Active comparator | After surgical or procedural correction of the underlying cause of heart failure (valvular surgery/TAVI or PCI/CABG), full guideline-directed medical therapy including ARNI and SGLT2 inhibitors is initiated and titrated to the maximally tolerated doses according to current heart failure guidelines, and continued throughout the follow-up period. All participants are followed for 12 months from randomization. Receives: Drug: Sacubitril / Valsartan; Drug: SGLT2 Inhibition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular ejection fraction (LVEF) at 12 months
Absolute change in left ventricular ejection fraction (LVEF), expressed in percentage points, from baseline (at randomization) to the 12-month follow-up assessment. LVEF will be measured by transthoracic echocardiography using the biplane Simpson's method according to current ASE/EACVI guidelines, and analyzed by readers blinded to treatment assignment.
The primary hypothesis is non-inferiority of the delayed-initiation strategy compared with the immediate-initiation strategy. Non-inferiority will be declared if the lower bound of the two-sided 95% confidence interval for the between-group difference in LVEF change (delayed minus immediate) lies above -5 percentage points; that is, the LVEF improvement in the delayed-initiation arm is no more than 5 percentage points worse than in the immediate-initiation arm.
Measured: Baseline (at randomization) and 12 months after randomization
Secondary outcomes (10)
Cardiovascular mortality
Incidence of death from cardiovascular causes, including death from heart failure, sudden cardiac death, myocardial infarction, stroke, and other cardiovascular causes, adjudicated by an independent clinical events committee blinded to treatment assignment.
Measured: From randomization through 12 months
Heart failure hospitalization
Incidence of hospitalization due to worsening heart failure, defined as an unplanned admission with signs and symptoms of heart failure requiring intensification of decongestive therapy (intravenous diuretics, vasodilators, or inotropes), adjudicated by an independent clinical events committee blinded to treatment assignment.
Measured: From randomization through 12 months
Change in echocardiographic remodeling parameters at 12 months
Change from baseline to 12 months in the following echocardiographic parameters measured by transthoracic echocardiography: left ventricular end-diastolic diameter (LVEDD), left ventricular end-diastolic volume index (LVEDVI), left atrial volume index (LAVI), and right ventricular ejection fraction (RVEF).
Measured: Baseline and 12 months after randomization
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Change from baseline to 12 months in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, a disease-specific health status measure for heart failure. Scores range from 0 to 100, with higher scores indicating better health status and quality of life.
Measured: Baseline and 12 months after randomization
Change in 6-minute walk distance (6MWD)
Change from baseline to 12 months in the distance walked (in meters) during a standardized 6-minute walk test, conducted according to American Thoracic Society guidelines.
Measured: Baseline and 12 months after randomization
Non-cardiovascular hospitalization
Incidence of hospitalization due to causes other than cardiovascular events.
Measured: From randomization through 12 months
Change in NT-proBNP from baseline
Change from baseline to 12 months in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration (pg/mL), a biomarker of myocardial wall stress and heart failure severity.
Measured: Baseline and 12 months after randomization
Proportion of patients in whom ARNI/SGLT2i is deemed unnecessary
Among patients in the delayed-initiation arm, the proportion whose LVEF has recovered to >40% at the 6-month assessment and who therefore do not require initiation of ARNI and SGLT2 inhibitors under the trial protocol. This is an exploratory outcome intended to estimate the fraction of patients who may safely avoid these therapies after correction of the underlying cause of heart failure.
Measured: 6 months after randomization
LVEF recovery in patients with spontaneous recovery versus medication-treated recovery
Among patients in the delayed-initiation arm whose LVEF recovers spontaneously (without ARNI or SGLT2i) by the 6-month assessment, the magnitude of LVEF recovery at 12 months will be compared with that in patients in the immediate-initiation arm whose recovery occurred while receiving ARNI and SGLT2i.
Measured: Baseline, 6 months, and 12 months after randomization
Cost-effectiveness analysis (Incremental Cost-Effectiveness Ratio, ICER)
Cost-effectiveness of the delayed-initiation strategy compared with the immediate-initiation strategy, expressed as an incremental cost-effectiveness ratio (ICER) using cost per quality-adjusted life-year (QALY) gained, from the healthcare-system perspective. Direct medical costs (medications, hospitalizations, outpatient visits, procedures) and quality-of-life weights derived from the KCCQ will be incorporated into the analysis.
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start20 May 2026
- Primary completion20 May 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure Due to Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1 - Delayed-initiation group (Experimental): After correction of the underlying cause, ARNI and SGLT2i are withheld and patients are observed for 6 months on background therapy (excluding ARNI/SGLT2i). At the 6-month assessment, ARNI and SGLT2i are initiated only in patients whose LVEF remains ≤40%. Patients whose LVEF has recovered to \>40% continue without ARNI/SGLT2i and remain under observation. If symptomatic heart failure worsening or a ≥10 percentage-point drop in LVEF occurs during the observation period, full GDMT including ARNI/SGLT2i is started immediately as rescue therapy. Arm 2 - Immediate-initiation group (Active Comparator): After correction of the underlying cause, full guideline-directed medical therapy including ARNI and SGLT2i is initiated and titrated according to current heart failure guidelines, and continued throughout follow-up.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungsub Song
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Korea University Anam Hospital, Ajou University School of Medicine
- Responsible party
- Sponsor-investigator, Kyungsub Song, Keimyung University Dongsan Medical Center
- Investigators
- Kyungsub Song, MD, Study director, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572032
- Sponsor's protocol ID
- 2026-04-005-001 April 21, 2026
- Other IDs
- RS-2026-25475665
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) underlying the published results, including baseline demographic and clinical characteristics, echocardiographic parameters (LVEF, LV volumes, diastolic indices), laboratory values (NT-proBNP, eGFR, electrolytes), KCCQ-12 scores, 6-minute walk distance, randomization assignment, study drug exposure, and adjudicated clinical events (cardiovascular and all-cause mortality, heart failure hospitalization, MACE), will be made available. The full study protocol, statistical analysis plan, and informed consent form will also be shared. Only deidentified data without any direct or indirect identifiers will be released, in accordance with the Personal Information Protection Act of the Republic of Korea and the Bioethics and Safety Act.
Publications
1. Wilcox JE et al. Heart Failure With Recovered LVEF: JACC Scientific Expert Panel. JACC 2020;76(6):719-34. 2. Kodur N, Tang WHW. Management of HFimpEF: Current Evidence and Controversies. JACC Heart Fail 2025;13(4):537-53. 3. Velazquez EJ et al. Coronary-Artery Bypass Surgery in Patients with Ischemic Cardiomyopathy (STICH). N Engl J Med 2011;364:1607-16. 4. Myocardial Revascularization in Patients With Ischemic Cardiomyopathy. J Am Heart Assoc 2022. 5. Recovery of LV Function After Surgery for Aortic and Mitral Regurgitation With HF. J Cardiovasc Dev Dis 2024. 6. Halliday BP et al. Withdrawal of pharmacological treatment for HF in patients with recovered DCM (TRED-HF). Lancet 2019;393:61-73. 7. Cheng RK et al. Long-term follow-up of TRED-HF. Eur J Heart Fail 2025;27:113-21. 8. Heidenreich PA et al. 2022 AHA/ACC/HFSA Guideline for Management of Heart Failure. Circulation 2022;145:e895-e1032. 9. Bocchi EA et al. Carvedilol as Single Therapy for HFimpEF (CATHEDRAL-HF). JACC Heart Fail 2025;13(7):882-91. 10. Hawkins NM et al. Withdrawal of HF therapy after AF rhythm control with EF normalization (WITHDRAW-AF). Eur Heart J 2026;47(2):250-60. 11. ReReRe study: Withdrawal of GDMT in patients with recovered LV and reversible etiology in valvular regurgitation. Eur Heart J 2025;46(Suppl 1):ehaf784.1245. 12. Sauer AJ et al. How to Initiate and Uptitrate GDMT in Heart Failure. JACC Heart Fail 2023;11(1):21-30. 13. Early Initiation of GDMT for Heart Failure After Cardiac Surgery. Ann Thorac Surg 2024;118(4):887-94. 14. Whitehead AL et al. Estimating the sample size for a pilot randomised trial. Pilot Feasibility Stud 2016;2:17.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected aetiologY (DELAY-HF), Pilot Study
- ClinicalTrials.gov ID
- NCT07572032
- Acronym / sponsor ID
- 2026-04-005-001 April 21, 2026
- Keywords
- Heart failure, Recovered ejection fraction, ARNI (Angiotensin receptor-neprilysin inhibitor), SGLT2 inhibitor, Valvular heart disease, Ischemic cardiomyopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kyungsub SongUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Korea University Anam Hospital, Ajou University School of Medicine
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 May 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Scientific Background and Rationale Contemporary heart failure (HF) guidelines recommend the early and simultaneous initiation of the four foundational pillars of guideline-directed medical therapy (GDMT)-ARNI (or ACEi/ARB), beta-blocker, mineralocorticoid receptor antagonist, and SGLT2 inhibitor-in patients with a reduced left ventricular ejection fraction (LVEF). The pivotal trials supporting these recommendations, however, were conducted predominantly in patients with chronic HFrEF in whom the underlying aetiology was either non-correctable or had not been definitively addressed. A clinically distinct population is encountered when the underlying cause of heart failure is fully reversible: patients with ischaemic cardiomyopathy who undergo complete revascularization, and patients with left-sided valvular disease causing chronic pressure or volume overload (severe aortic stenosis, aortic regurgitation, primary mitral regurgitation) who undergo valvular surgery or transcatheter intervention. In these patients, removal of the haemodynamic insult itself drives a substantial portion of subsequent LVEF recovery, independent of neurohormonal blockade. Consequently, universal and immediate initiation of ARNI and SGLT2i in this population may expose patients who would have recovered spontaneously to drug-related adverse effects (symptomatic hypotension, hyperkalaemia, renal dysfunction, genitourinary infection, ketoacidosis), to the burden of polypharmacy, and to avoidable cost, with uncertain incremental benefit on cardiac function or clinical outcome. The optimal timing of ARNI and SGLT2i initiation in patients whose underlying cause of HF has been definitively corrected has not been prospectively examined.
- Study Hypothesis The central hypothesis of DELAY-HF is that, in patients in whom the underlying cause of heart failure has been surgically or procedurally corrected, the LVEF recovery attributable to treatment of the underlying cause is substantially greater than the incremental recovery attributable to ARNI and SGLT2i. Under this hypothesis, the 12-month LVEF change in the delayed-initiation arm is expected to be no more than 5 percentage points worse than in the immediate-initiation arm. As a pilot trial, DELAY-HF estimates this difference with a 95% confidence interval and evaluates it against the pre-specified decision criterion; a formal non-inferiority hypothesis test will be performed in a subsequent, separately designed confirmatory trial.
- Pre-specified Analyses
Four pre-specified analyses are planned to fully characterise the contribution of ARNI/SGLT2i in this population:
- Effect of early ARNI/SGLT2i on LVEF recovery. Patients in the delayed-initiation arm who never received ARNI/SGLT2i during the 12-month follow-up (those without recovery at 6 months who were ultimately not started, plus those who recovered spontaneously) will be compared with the immediate-initiation arm to estimate the contribution of early ARNI/SGLT2i to LVEF recovery beyond the recovery driven by treatment of the underlying cause.
- Safety of delayed initiation. Within the delayed-initiation arm, patients who received delayed ARNI/SGLT2i and recovered will be compared with those who received delayed therapy without recovery, to evaluate whether postponing therapy by 6 months in non-recovering patients is associated with an attenuation of subsequent LVEF response.
- Twelve-month head-to-head comparison. The proportion of patients achieving LVEF recovery and the magnitude of LVEF improvement at the 12-month assessment will be compared directly between the delayed-initiation and immediate-initiation arms.
- Spontaneous versus pharmacologic recovery. Among patients in the delayed-initiation arm whose LVEF recovered spontaneously after correction of the underlying cause (without medication), the magnitude of LVEF recovery will be compared with that achieved in patients in the immediate-initiation arm whose recovery occurred while on ARNI/SGLT2i.
- Sample Size Justification Sample Size Justification. The sample size of 80 patients (40 per arm) was not derived from a power calculation for hypothesis testing, in keeping with the exploratory purpose of a pilot trial. It is based on: (1) the recommendation of Whitehead et al. (2016) of 25-40 participants per arm for a pilot trial preceding a main trial with a standardised effect size of 0.5 (decision margin Δ = 5 percentage points, assumed SD ≈ 10 percentage points); (2) consistency with prior randomised trials of GDMT withdrawal in recovered heart failure (ReReRe n = 80, TRED-HF n = 51, CATHEDRAL-HF n = 60); (3) detection of a safety signal-approximately 80% power (Fisher's exact test, α = 0.05) to detect a rescue-therapy rate of 25% in the delayed arm versus 5% in the immediate arm; (4) estimation of feasibility metrics (recruitment, adherence, 12-month follow-up completion) within a 95% confidence interval of approximately ±10 percentage points; and (5) an allowance of 10%
- Exploratory Analyses A pre-specified exploratory aim of the trial is to estimate the proportion of patients in the delayed-initiation arm in whom ARNI and SGLT2i can ultimately be deemed unnecessary-that is, those whose cardiac function has recovered sufficiently at 6 months that initiation is not warranted under the trial protocol. A formal cost-effectiveness analysis (incremental cost-effectiveness ratio) will compare the two strategies from the healthcare-system perspective.
- Expected Implications If the delayed-initiation strategy proves safe and feasible in this pilot, with no clinically important signal of harm on the LVEF decision criterion, the findings will support a subsequent confirmatory trial and, ultimately, a more individualised prescribing approach in patients with a corrected cause of heart failure-reserving ARNI and SGLT2i for those who fail to recover spontaneously-thereby reducing unnecessary drug exposure, adverse-effect burden, and cost in a population that is currently treated uniformly under generalised HFrEF guidelines.
- Safety Monitoring Safety Monitoring. An independent Data and Safety Monitoring Board (DSMB) will perform two interim safety reviews: after the first 40 patients complete 12-month follow-up and after enrolment of 80 patients. Safety data from the intensive 6-month observation period of the delayed-initiation arm (rescue-therapy rate, heart failure hospitalisation, death) will be reviewed separately by aetiology (valvular vs ischaemic). A rescue-therapy rate exceeding 20% in the delayed-initiation arm triggers a DSMB review, and stratum-specific discontinuation of enrolment may be recommended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1 - Delayed-initiation group (Experimental): After correction of the underlying cause, ARNI and SGLT2i are withheld and patients are observed for 6 months on background therapy (excluding ARNI/SGLT2i). At the 6-month assessment, ARNI and SGLT2i are initiated only in patients whose LVEF remains ≤40%. Patients whose LVEF has recovered to >40% continue without ARNI/SGLT2i and remain under observation. If symptomatic heart failure worsening or a ≥10 percentage-point drop in LVEF occurs during the observation period, full GDMT including ARNI/SGLT2i is started immediately as rescue therapy. Arm 2 - Immediate-initiation group (Active Comparator): After correction of the underlying cause, full guideline-directed medical therapy including ARNI and SGLT2i is initiated and titrated according to current heart failure guidelines, and continued throughout follow-up.
| Arm | Type | Receives |
|---|---|---|
| Delayed initiation of ARNI and SGLT2i | Experimental | Drug: Sacubitril / Valsartan, Drug: SGLT-2 inhibitorAfter surgical or procedural correction of the underlying cause of heart failure (valvular surgery/TAVI or PCI/CABG), ARNI and SGLT2 inhibitors are withheld and patients are observed for 6 months on background therapy excluding ARNI/SGLT2i. At the 6-month assessment, ARNI and SGLT2i are initiated only in patients whose LVEF remains ≤40%. Patients with LVEF >40% continue without ARNI/SGLT2i under observation. If symptomatic heart failure worsening or a ≥10 percentage-point decrease in LVEF occurs during the observation period, full guideline-directed medical therapy including ARNI and SGLT2i is started immediately as rescue therapy. All participants are followed for 12 months from randomization. |
| Immediate initiation of ARNI and SGLT2i (standard GDMT) | Active comparator | Drug: Sacubitril / Valsartan, Drug: SGLT2 InhibitionAfter surgical or procedural correction of the underlying cause of heart failure (valvular surgery/TAVI or PCI/CABG), full guideline-directed medical therapy including ARNI and SGLT2 inhibitors is initiated and titrated to the maximally tolerated doses according to current heart failure guidelines, and continued throughout the follow-up period. All participants are followed for 12 months from randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril / ValsartanIn the delayed-initiation arm, sacubitril/valsartan is withheld for 6 months after the corrective procedure; valsartan is used for blood pressure control and background heart failure therapy. At the 6-month assessment, sacubitril/valsartan is initiated only in patients with LVEF ≤40%. Patients with LVEF >40% continue their existing regimen without ARNI. If heart failure worsens during observation (symptomatic deterioration or a ≥10 percentage-point drop in LVEF), sacubitril/valsartan is started immediately as rescue therapy. Patients on ARNI prior to enrollment undergo a 1-week washout before randomization. | Drug | Delayed initiation of ARNI and SGLT2i |
| SGLT-2 inhibitorIn the delayed-initiation arm, the SGLT2 inhibitor (dapagliflozin 10 mg once daily or empagliflozin 10 mg once daily) is withheld during the first 6 months and initiated at the 6-month assessment only in patients whose LVEF remains ≤40%; patients whose LVEF has recovered to >40% continue without SGLT2i under observation. If heart failure worsens during the observation period, the SGLT2 inhibitor is started immediately as rescue therapy. Patients receiving SGLT2i prior to enrollment undergo a 1-week washout before randomization. | Drug | Delayed initiation of ARNI and SGLT2i |
| Sacubitril / ValsartanIn the immediate-initiation arm, sacubitril/valsartan is started within 7 days after the corrective procedure, once the patient is hemodynamically stable and euvolemic. The starting dose is selected based on baseline blood pressure (25 mg to 200 mg twice daily) and titrated to the maximally tolerated dose (target 200 mg twice daily), continued throughout the 12-month follow-up. | Drug | Immediate initiation of ARNI and SGLT2i (standard GDMT) |
| SGLT2 InhibitionAn SGLT2 inhibitor (dapagliflozin 10 mg once daily or empagliflozin 10 mg once daily, at the discretion of the treating physician) is used as one of the foundational therapies of guideline-directed medical therapy for heart failure. In the immediate-initiation arm, the SGLT2 inhibitor is started after correction of the underlying cause of heart failure and continued throughout the 12-month follow-up. | Drug | Immediate initiation of ARNI and SGLT2i (standard GDMT) |
Primary outcome
Change in left ventricular ejection fraction (LVEF) at 12 months
Time frame: Baseline (at randomization) and 12 months after randomization
Absolute change in left ventricular ejection fraction (LVEF), expressed in percentage points, from baseline (at randomization) to the 12-month follow-up assessment. LVEF will be measured by transthoracic echocardiography using the biplane Simpson's method according to current ASE/EACVI guidelines, and analyzed by readers blinded to treatment assignment. The primary hypothesis is non-inferiority of the delayed-initiation strategy compared with the immediate-initiation strategy. Non-inferiority will be declared if the lower bound of the two-sided 95% confidence interval for the between-group difference in LVEF change (delayed minus immediate) lies above -5 percentage points; that is, the LVEF improvement in the delayed-initiation arm is no more than 5 percentage points worse than in the immediate-initiation arm.
10 secondary outcomes
Cardiovascular mortality
Time frame: From randomization through 12 months
Heart failure hospitalization
Time frame: From randomization through 12 months
Change in echocardiographic remodeling parameters at 12 months
Time frame: Baseline and 12 months after randomization
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: Baseline and 12 months after randomization
Change in 6-minute walk distance (6MWD)
Time frame: Baseline and 12 months after randomization
Non-cardiovascular hospitalization
Time frame: From randomization through 12 months
Change in NT-proBNP from baseline
Time frame: Baseline and 12 months after randomization
Proportion of patients in whom ARNI/SGLT2i is deemed unnecessary
Time frame: 6 months after randomization
LVEF recovery in patients with spontaneous recovery versus medication-treated recovery
Time frame: Baseline, 6 months, and 12 months after randomization
Cost-effectiveness analysis (Incremental Cost-Effectiveness Ratio, ICER)
Time frame: 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Results publication1. Wilcox JE et al. Heart Failure With Recovered LVEF: JACC Scientific Expert Panel. JACC 2020;76(6):719-34. 2. Kodur N, Tang WHW. Management of HFimpEF: Current Evidence and Controversies. JACC Heart Fail 2025;13(4):537-53. 3. Velazquez EJ et al. Coronary-Artery Bypass Surgery in Patients with Ischemic Cardiomyopathy (STICH). N Engl J Med 2011;364:1607-16. 4. Myocardial Revascularization in Patients With Ischemic Cardiomyopathy. J Am Heart Assoc 2022. 5. Recovery of LV Function After Surgery for Aortic and Mitral Regurgitation With HF. J Cardiovasc Dev Dis 2024. 6. Halliday BP et al. Withdrawal of pharmacological treatment for HF in patients with recovered DCM (TRED-HF). Lancet 2019;393:61-73. 7. Cheng RK et al. Long-term follow-up of TRED-HF. Eur J Heart Fail 2025;27:113-21. 8. Heidenreich PA et al. 2022 AHA/ACC/HFSA Guideline for Management of Heart Failure. Circulation 2022;145:e895-e1032. 9. Bocchi EA et al. Carvedilol as Single Therapy for HFimpEF (CATHEDRAL-HF). JACC Heart Fail 2025;13(7):882-91. 10. Hawkins NM et al. Withdrawal of HF therapy after AF rhythm control with EF normalization (WITHDRAW-AF). Eur Heart J 2026;47(2):250-60. 11. ReReRe study: Withdrawal of GDMT in patients with recovered LV and reversible etiology in valvular regurgitation. Eur Heart J 2025;46(Suppl 1):ehaf784.1245. 12. Sauer AJ et al. How to Initiate and Uptitrate GDMT in Heart Failure. JACC Heart Fail 2023;11(1):21-30. 13. Early Initiation of GDMT for Heart Failure After Cardiac Surgery. Ann Thorac Surg 2024;118(4):887-94. 14. Whitehead AL et al. Estimating the sample size for a pilot randomised trial. Pilot Feasibility Stud 2016;2:17.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) underlying the published results, including baseline demographic and clinical characteristics, echocardiographic parameters (LVEF, LV volumes, diastolic indices), laboratory values (NT-proBNP, eGFR, electrolytes), KCCQ-12 scores, 6-minute walk distance, randomization assignment, study drug exposure, and adjudicated clinical events (cardiovascular and all-cause mortality, heart failure hospitalization, MACE), will be made available. The full study protocol, statistical analysis plan, and informed consent form will also be shared. Only deidentified data without any direct or indirect identifiers will be released, in accordance with the Personal Information Protection Act of the Republic of Korea and the Bioethics and Safety Act.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyungsub Song, MD study director
Keimyung University Dongsan Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sacubitril / Valsartan, SGLT-2 inhibitor and SGLT2 Inhibition in people with Heart Failure Due to Coronary Artery Disease and Valvular Cardiomyopathy, run by Kyungsub Song at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyungsub Song, MD (82)053-258-7307, chest.songks@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular ejection fraction (LVEF) at 12 months (time frame: Baseline (at randomization) and 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07572032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.