None listed
Conditions
Interventions
Drug : Patients with a correctable cause of heart failure (i.e., valvular heart disease or ischemic cardiomyopathy) who have undergone surgical or interventional correction of the underlying cause, ac
Sponsors
Keimyung University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a documented left ventricular ejection fraction (LVEF) =40% prior to corrective surgery or intervention, with recovery to =50% (within the normal range) at the time of enrollment. N-terminal pro-B-type natriuretic peptide (NT-proBNP) <250 ng/L. Patients whose underlying correctable cause of heart failure has been completely corrected by surgery or intervention, including: Surgical or transcatheter correction of valvular heart disease (mitral regurgitation, aortic stenosis, or aortic regurgitation); or Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for ischemic cardiomyopathy. Patients receiving both ARNI and SGLT2i therapy for at least 3 months at the time of enrollment. Additional treatment with an MRA and/or beta-blocker is permitted. Clinically stable outpatients with no hospitalization for heart failure within the previous 6 months. Patients who voluntarily provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Patients meeting one or more of the following criteria: Heart failure caused by a non-correctable etiology (e.g., idiopathic dilated cardiomyopathy, toxic cardiomyopathy, or genetic cardiomyopathy). In patients with valvular heart disease, the presence of moderate or greater paravalvular leak, or residual mitral or aortic regurgitation of moderate or greater severity after correction. In patients with coronary artery disease, incomplete revascularization, or evidence of graft occlusion on postoperative coronary computed tomography (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). Women who are pregnant, suspected to be pregnant, or breastfeeding. Patients with terminal malignancy or end-stage organ failure with a life expectancy of less than 12 months. Participation in another clinical trial within 3 months prior to screening. Any patient whom the investigator considers unsuitable for participation in the study for clinical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in left ventricular ejection fraction (LVEF) at 12 months after randomization, defined as the absolute difference (%) from baseline.; left ventricular ejection fraction (LVEF) defined as the absolute difference (%) from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite clinical outcome: incidence of the composite endpoint of cardiovascular death and hospitalization for heart failure within 12 months.;Change in left ventricular ejection fraction (LVEF) at 12 months.;Change in caridac enzyme( NT-proBNP) levels at 3 and 12 months.;Change in New York Heart Association (NYHA) functional class.;Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall score (quality of life).;Change in 6-minute walk distance (6MWD).;Incidence and severity of adverse drug reactions/events.;Rate of medication re-initiation and time to medication re-initiation following withdrawal. | — |
Countries
Korea, Republic of
Contacts
Public Contactsohyeon Park
Keimyung University Dongsan Hospital
Outcome results
None listed