Impacts of Sacubitril-Valsartan versus Valsartan on Left Ventricular Remodeling and Cardiac Function in Patients with Ischemic Heart Failure and Reduced Ejection Fraction: A Randomized Double-Blinded Controlled Trial.

Introduction: Sacubitril/valsartan (SAC/VAL) is a combination medication primarily used to treat heart failure with reduced ejection fraction (HFrEF). This randomized controlled trial (RCT) assessed the impacts of SAC/VAL compared with valsartan (VAL) on left ventricular (LV) remodeling, clinical outcomes, and cardiac function in patients with HFrEF.

Methods: A single-blinded run-in phase and a double-blinded treatment phase were conducted at Imam Hospital (Ahvaz, Iran) among 106 patients (SAC/VAL group: n=54; VAL group=52). Patients were randomly assigned to receive a combination of SAC/VAL (up-titrated to the target dosage of 200 mg, twice daily) or VAL (up-titrated to 160 mg, twice daily) for a six-month of intervention. Patients' clinical, demographic, and echocardiographic data were collected before and after the intervention.

Results: After a six-month intervention, statistically significant mean differences were detected in various echocardiographic parameters (e.g., LV end-systolic volume, LV ejection fraction, and LV end-diastolic volume) within each group and between the two groups. Significant mean differences were noted in the six-minute walk test, serum levels of blood urea nitrogen, aspartate aminotransferase, sodium, creatinine, alanine aminotransferase, N-terminal pro-B-type natriuretic peptide, and scores of the Kansas City Cardiomyopathy questionnaire in post-intervention assessments within each group and between the two groups (P <0.05). There was a substantial within-group difference in the frequency of the New York Heart Association (NYHA) functional class from pre- to post-intervention (P <0.05).

Discussion: This study revealed that SAC/VAL exhibited superior efficacy compared to VAL. However, the follow-up period was relatively short, and the potential risks associated with the prolonged administration of this medication have not been thoroughly evaluated.

Conclusion: This RCT indicated that the combination of SAC/VAL had better therapeutic effects than VAL on LV remodeling, clinical outcomes, and cardiac function in patients with ischemic HFrEF. These findings may help refine treatment priorities for patients with HFrEF and improve the quality of their care.

Clinical trial registration number: IRCT20240117060713N1.