💬In plain words
What the trial is, and whether it could suit you
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,
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Sacubitril / Valsartan
- SGLT-2 inhibitor
- Sacubitril / Valsartan
- SGLT2 Inhibition
Keimyung University Dongsan Hospital
Daegu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Ajou University Hospital
Suwon, South Korea
Korea University Anam Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky