Efficacy of sacubitril/valsartan among patients with chronic heart failure with reduced ejection fraction

Abstract

Objective: Chronic heart failure is one of the leading causes of hospitalization and recurrent admissions among the elderly population worldwide. This study was conducted to determine the efficacy of Sacubitril/Valsartan among heart failure cases with reduced left ventricular ejection fraction.

Methods: This prospective simple experimental study was conducted over a 6-month duration from Feb. 1^st, 2023 to July 30^th, 2023 at Islamabad Medical Complex after ethical approval. Adult patients (≥ 25 years of age; both genders) presenting with chronic heart failure (CHF) with LVEF ≤ 40% for ≥ 3 months duration; NYHA-II/III/ambulatory-IV, ischemic/non-ischemic cardiomyopathy cases were included by consecutive non-probability sampling. Systolic blood pressure (SBP)<100mmHg, eGFR<30mL/min/m², serum potassium>4.5mEq/L, known drug reactions, and congenital heart disease cases were excluded. After detailed clinical evaluation, baseline ejection fraction (EF), and NT Pro-BNP levels were documented. Patients were started on Sacubitril/valsartan and followed every 2 months till 6 months duration. EF, NT Pro-BNP levels re-checked at 6^th month. The primary endpoint was EF improvement at 6 months. Secondary endpoints were all-cause mortality or hospitalization due to heart failure. Data was analyzed by SPSS V-25, with significant p<0.05.

Results: Amongst 100 cases, (63% males; 37% females), 10% patients were 29-45 years, 49% (46-60 years) and 41% (61-75 years). 13% of cases had CABG, 30% had PCI, and 55% had no previous cardiac invention. 57 patients received dose-50/day and 43 received dose-100/day. At baseline, 79 patients had NYHA-II, 17(NYHA-III) and 4(NYHA-IV). After six months, 78 patients had NYHA-II, 2(NYHA-III) and 1(NYHA-IV). 12 patients lost to follow-up, 4 expired, while therapy stopped in 4 due to raised creatinine.  At baseline, 8 patients had no mitral regurgitation (MR), 4(trace MR), 48(mild MR), 25(moderate MR) and 15 had severe MR. After six months, 16 patients had no MR, 13(trace MR), 37(mild MR), 13(moderate MR) and 2 had severe MR. The statistically significant difference found in pro-BNP, creatinine, SBP, ejection fraction, E/e, E/A ratio, left ventricular end-diastolic volume (LEDV) and left ventricular end-systolic volume (LVESV) between baseline versus at six months (p<0.05).

Conclusion: In chronic heart failure cases with reduced ejection fraction (HFrEF), sacubitril/valsartan has proven to be significantly effective in improving NYHA class, degree of MR, cardiovascular mortality and Hospitalization.