Delayed Start of ARNI and SGLT2 Inhibitor in Recovered Heart Failure After Correctable Causes
Official title: DELayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected aetiologY (DELAY-HF), Pilot Study
Run by Keimyung University Dongsan Medical Center · NCT07572032 · Data updated 2026-11-12
This pilot study tests whether delaying ARNI and SGLT2 inhibitors in patients whose heart function recovers after fixing a correctable cause is safe and feasible.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Keimyung University Dongsan Medical Center Academic / other |
| Locations | 4 sites (Daegu, Daegu and 3 other locations) |
| Status | Recruiting |
| Started | May 20, 2026 |
| Main results expected | May 20, 2028 |
| Study ends | December 20, 2028 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07572032 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with HF with reduced EF who have undergone successful correction of a reversible cause and have stable post-procedure status.
✕Probably not a fit
Patients who do not experience adequate recovery or who remain hemodynamically unstable may not benefit from delaying therapy.
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, open-label trial with blinded endpoint assessment looks at patients whose heart failure with reduced ejection fraction improves after correcting reversible causes such as valvular disease or coronary artery disease. Participants are assigned to delay or initiate ARNI and SGLT2 inhibitors after recovery, to see if withholding these drugs affects safety and early outcomes. The study focuses on whether spontaneous recovery reduces the need for full GDMT and whether delaying these therapies avoids unnecessary side effects and polypharmacy. Primary concerns include the safety of delaying neurohormonal blockade while monitoring for stability after revascularization or valve intervention. The design aims to generate data to guide personalized treatment plans in a subset of heart failure patients.
Why it matters
Potential benefit: If successful, the approach could reduce unnecessary medication burden and adverse effects for patients whose heart function recovers after a reversible cause.
How similar studies have gone: There is limited prior evidence; this represents a novel pilot exploring delayed therapy in a specific, reversible HF population.
Who can join: the full rules
Show full inclusion / exclusion 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.
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 -
Korea University Anam Hospital
Seoul, Seoul, South Korea Not yet recruiting
Study contacts
- Study coordinator: Kyungsub Song, MD
- Email: chest.songks@gmail.com
- Phone: 82)053-258-7307
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.