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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 31, No 4, July/August 2020
196
AFRICA
Short-term efficacy and safety of levosimendan in
patients with chronic systolic heart failure
Xiao-Ran Cui, Xiao-Hong Yang, Rui-Bin Li, Dong Wang, Min Jia, Long Bai, Ji-Dong Zhang
Abstract
The objective was to investigate and evaluate the short-term
efficacy and safety of levosimendan in patients with chronic
systolic heart failure. Forty-nine patients with chronic systolic
heart failure during acute decompensation were randomly
divided into a levosimendan group (26 cases) and a control
group (23 cases). The control group received only routine
treatment, while the levosimendan group received a levosi-
mendan bolus with a load of 12 μg/kg, in addition to the
same routine treatment as the control group. After 48 hours
of treatment, N-terminal pro B-type natriuretic peptide
(NT-proBNP) levels in the levosimendan group were signifi-
cantly lower than those in the control group. In addition, the
left ventricular ejection fraction (LVEF) and New York Heart
Association (NYHA) cardiac function scores of the levosi-
mendan group were significantly higher and more improved
than those of the control group seven days after treatment,
but there was no significant difference in the left ventricular
end-diastolic diameter between the two groups. Furthermore,
48 hours after treatment, there were no significant differences
in potassium, haemoglobin, haematocrit and creatinine levels
between the levosimendan and control groups. During the
whole hospitalisation, there was one case of sudden death
in the control group and one case of palpitations in the
levosimendan group, and no hypotension or severe hypoka-
laemia occurred in either group. Levosimendan significantly
improved NT-proBNP and LVEF in patients with chronic
systolic heart failure, and improved NYHA cardiac func-
tion classification without significant cardiovascular events.
Levosimendan is therefore effective and safe in the short-term
treatment of chronic systolic heart failure.
Keywords:
levosimendan, chronic systolic heart failure, cardiac
function evaluation
Submitted 24/1/20, accepted 11/3/20
Published online 12/6/20
Cardiovasc J Afr
2020;
31
: 196–200
www.cvja.co.zaDOI: 10.5830/CVJA-2020-008
Heart failure (HF) is a serious and terminal stage of various heart
diseases. Chronic heart failure (CHF) is the gradual occurrence
of HF symptoms and signs resulting from the original chronic
heart disease. Worsening of the symptoms of chronic stable HF
represents decompensated HF,
1
which has a poor prognosis, will
seriously affect the quality of life of the patients, and will bring
a heavy burden to their families. It has become one of the major
public health problems in China.
2
For these chronic HF patients, drug therapy is still the
main treatment. Positive inotropic agents are an efficacious
drug for the treatment of HF patients with low-cardiac output
syndrome.
3,4
However, when these agents are used at high
doses, the risk of side effects increases, including increased
myocardial oxygen consumption, incidence of arrhythmia and
even mortality in patients with heart failure.
5
Cardiac troponin C (cTnC) is a molecular switch controlled
by calcium ions (Ca
2+
), which can change myocardial muscle
strength during cardiac contraction and diastole. Therefore,
the degree of myocardial contraction in diastole is regulated
by the binding properties of Ca
2+
and cTnC. As a new type
of Ca
2+
sensitiser, levosimendan has a dual action mechanism.
Compared with positive inotropic agents, levosimendan can
enhance the sensitivity of the myocardium to Ca
2+
and increase
the contractility of myocardial cells without affecting intracellular
Ca
2+
concentrations or increasing the risk of myocardial oxygen
consumption and with no malignant arrhythmia. In addition,
levosimendan can also mediate ATP-sensitive potassium
channels on smooth muscle cells to exert vasodilation, reduce
cardiac load and improve coronary artery blood supply.
6,7
A large number of evidence-based medical studies show that
levosimendan has advantages compared to traditional cardiac
tonic drugs.
8-11
The guidelines for diagnosis and treatment
of heart failure
1
suggest that levosimendan is not inferior to
dobutamine in alleviating clinical symptoms and improving
the prognosis of HF. It is used in systolic HF without severe
haemodynamic symptoms (class IIa recommendation, grade B
evidence). However, there are relatively few clinical studies and
safety evaluations for levosimendan. The aim of this study was
to evaluate the short-term efficacy and safety of levosimendan in
patients with acute decompensated chronic systolic HF.
Methods
The study protocol was approved by the ethics committee of the
Second Hospital of Hebei Medical University. Informed consent
was obtained from all the study subjects before enrollment.
Forty-nine patients with chronic systolic heart failure
hospitalised in the Department of Cardiology, Second
Hospital of Hebei Medical University from February 2017
to February 2018 were selected. The patients were randomly
divided into a levosimendan group (26 cases) and a control
group (23 cases).
The Sixth Department of Cardiovascular Medicine, Second
Hospital of Hebei Medical University, Shijiazhuang, Hebei,
China
Xiao-Ran Cui, MM
Xiao-Hong Yang, MD
Rui-Bin Li, MM
Dong Wang, MM
Min Jia, MD
Long Bai, MM
Ji-Dong Zhang, MD,
zhangjidong78@163.com