Use of levosimendan combined with Shenfu injection to treat acute heart failure patients with hypotension: a prospective randomized controlled single-blind study

Abstract

Background Levosimendan can improve clinical symptoms and the cardiorenal rescue success rate, and stabilize hemodynamic parameters in individuals suffering from acute decompensated heart failure. In addition, Shenfu injection (SFI) has been shown to protect the ischemic heart and enhance myocardial contractility. Methods For this randomized control single-blind study, 101 patients with acute decompensated heart failure (ADHF) were enrolled and randomly assigned to control levosimendan (n = 51) and levosimendan + SFI injection (n = 50) groups. Attending physicians were not blinded for which arm the patients were allocated. Blood pressure, heart rate, the electrocardiogram, respiratory rate, fluid intake and urine output were all recorded 2 h and 24 h after drug infusions had commenced, and the cardiac index (CI) was monitored by ultrasonic cardiac output monitors. Results Median blood pressure was markedly increased in the levosimendan + SFI group after 2 h and 24 h from the initiation of infusions compared to levosimendan administration alone. Brain natriuretic peptide (BNP) concentrations were reduced after administrations of levosimendan + SFI or solely levosimendan (both P < 0.001). Alterations in BNP concentrations were not different in the combination and control groups. No differences were found between the 2 groups in heart rate or severe hypotension, but blood pressure (systolic blood pressure, diastolic blood pressure) and hemodynamic parameters including CI, cardiac output and stroke volume index responded better in the levosimendan + SFI group compared to the monotherapy levosimendan group. Conclusions Levosimendan + SFI was superior to treat ADHF patients compared to levosimendan monotherapy and produced significant improvements in hemodynamic parameters especially for ADHF patients with hypotension. Trail registration The study was prospectively registered at Chinese Clinical Trial Registry with registration number [ChiCTR2000039385] (10/25/2020).

Effectiveness and safety of Danshen injections in treatment of cardiac failure: a network meta-analysis

“…The full texts of 193 papers were meticulously reviewed to select eligible studies, strictly adhering to the predefined inclusion and exclusion criteria. Finally, 24 studies were incorporated into the meta-analysis ( Li, 2011 ; Hu, 2012 ; Tang, 2013 ; Hu, 2015 ; Wang and Gao, 2015 ; Zeng et al, 2015 ; Zhang et al, 2015 ; Jiang et al, 2016 ; Li, 2016 ; Lyu et al, 2016 ; Qin and Jiang, 2016 ; Xian et al, 2016 ; Qiao, 2017 ; Yao, 2018 ; Shang and Lyu, 2019 ; Wang et al, 2019 ; Wang et al, 2020 ; Li et al, 2022b ). The literature screening process is shown in Figure 1 .…”

“…In addition to monotherapy, Miaomiao Li et al have also compared the effects of Shenfu Injection + Levosimendan and Levosimendan alone in acute heart failure (AHF). Their study is a single-blind RCT, with 101 patients enrolled, and has revealed that the efficacy of combined medication in AHF is better ( Li et al, 2022b ).…”

New approach to heart failure: Integrated traditional Chinese with Western medicine

“…In a multicenter, randomized, double‐blinded, placebo‐controlled trial involving 160 patients with acute phase chronic HF, the proportion of NYHA and TCM syndrome score improvements in the Shenfu injection group was significantly higher compared to the placebo group (78.38% vs. 89.19% and 61.43% vs. 60.00%, respectively; p < 0.05) [68]. Other studies have also shown that Shenfu injection can enhance hemodynamic parameters such as CI, CO, and SV in acute HF patients [69]. Multiple small‐sample RCTs suggest that it can also improve ventricular diastolic function and quality of life in HFpEF patients [70–72].…”

Hypertensive heart disease: risk factors, complications and mechanisms

“…In addition, individualized nutritional support as well as treatment with vericiguat for hospitalized patients with heart failure is also beneficial in reducing the risk for death and morbidity ( 241 – 243 ). Further, in patients with acute decompensated heart failure, usage of levosimendan in combination with Shenfu injection was effective in improving hemodynamics and enhance myocardial contractility ( 244 ). In severe heart failure where therapy is limited, use of omecamtiv mecarbil therapy is reported to have beneficial effects in reducing adverse outcomes ( 245 ).…”