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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 31, No 4, July/August 2020
AFRICA
197
Inclusion criteria were (1) male or female patients aged 18 to 75
years who were hospitalised for acute episodes of chronic systolic
HF; (2) New York Heart Association (NYHA) classification
grade III or above at admission;
12
(3) echocardiogram showing left
ventricular ejection fraction (LVEF) ≤ 40% and left ventricular
end-diastolic diameter (LVEDD) ≥ 55 mm.
Exclusion criteria were (1) patients with a previous history
of malignant arrhythmia, such as ventricular tachycardia,
ventricular flutter and ventricular fibrillation; (2) patients with
severe liver or kidney dysfunction [estimated glomerular filtration
rate (eGFR)
<
30 ml/min/1.73 m
2
]; (3) patients with mechanical
obstructive diseases that significantly affect ventricular filling and/
or ejection function; (4) heart failure caused by acute myocardial
infarction (within 24 hours), severe primary valvular stenosis and
pericardial disease; (5) secondary HF caused by systemic diseases,
such as severe anaemia (haemoglobin
<
60 g/l), hyperthyroidism
and heart disease; (6) severe hypotension (systolic blood pressure
<
90 mmHg); (7) allergy to levosimendan or its accessories; (8)
patients or their families refusing to use levosimendan.
The experimental drugwas levosimendan5ml; 12.5mg,Yuewen,
Qilu Pharmaceutical Co, Ltd. The instruments for testing were
AC-T 5diff automatic five-classification haematology analyser,
Beckmann Kurt Company, USA, 800 automatic biochemical
analyser, Roche, USA, AQT90 FLEX immunoanalyser, Reddle,
Denmark, and IE33 echocardiography, Philips.
The control group received only routine treatment (including
diuretics, beta-blockers, angiotensin converting enzyme inhibitors
or angiotensin II receptor antagonists), while the levosimendan
group received a levosimendan bolus with a load of 12 μg/kg,
in addition to the same routine treatment as the control group.
Levosimendan was administered by maintenance intravenous
infusion at a rate of 0.1 μg/kg/min for 24 hours after 10 minutes
of intravenous bolus. For patients with systolic blood pressure
(SBP)
<
100 mmHg, the maintenance dose can be used directly
without the load dose. During the treatment period, clinicians
should closely observe the patient’s condition and monitor for
adverse drug reactions or major cardiovascular events.
The values of N-terminal B-type natriuretic peptide
(NT-proBNP), blood potassium (K
+
), haemoglobin (HGB),
haematocrit (HCT) and creatinine (Cr) were measured before
and 48 hours after treatment. At admission and seven days
after administration, LVEF and LVEDD were determined by
echocardiography, and NYHA cardiac function was graded. The
results of LVEF and LVEDD were reviewed by two ultrasound
doctors.
The incidence of adverse cardiac events such as headache,
hypotension, ventricular tachycardia and sudden death was
recorded during the treatment. The patients were followed up for
one month after discharge, and the re-hospitalisation rates of the
two groups were determined.
Statistical analysis
SPSS17.0 was used for statistical data analysis. All measurement
data are expressed as mean
±
SD. Before and after treatment,
a paired-samples
t-
test was used for comparison within groups
and an independent samples
t-
test was used for comparison
between groups. The basic clinical data between the two groups
were examined with a
χ
2
test. A
p
-value
<
0.05 was taken as a
statistically significant difference.
Results
There was no significant difference in clinical data between the
levosimendan and control groups (Table 1). There was also no
significant difference in indicators of detection between the
levosimendan and control groups (Table 2).
Before treatment, NT-proBNP values of the levosimendan
and control groups were 4715.60
±
6881.17 and 4380.39
±
4350.10
pg/ml, respectively. There was no significant difference between
the two groups. At 48 hours after treatment, NT-proBNP
values of the levosimendan and control groups were 1801.08
±
1947.43 and 3221.57
±
2833.16 pg/ml, respectively. NT-proBNP
was significantly downregulated in both groups. At 48 hours,
NT-proBNP was significantly lower in the levosimendan-treated
group compared to the control group (Fig. 1, Table 3).
Before treatment, the LVEF of the levosimendan and control
groups was 30.24
±
7.19 and 33.35
±
4.66%, respectively. There was
no significant difference between the two groups. After seven days
of treatment, the LVEF was 38.90
±
8.97% in the levosimendan
group and 34.57
±
5.51% in the control group, which was
significantly higher than that before treatment. In addition, the
LVEF in the levosimendan group was statistically higher than that
in the control group after treatment (Fig. 2, Table 4).
Similar results were shown in LVEDD. Before treatment,
there was no significant difference in LVEDD between the two
groups. However, compared with before the treatment, LVEDD
Table 1. Basic clinical data between the two groups
Clinical parameters
Levosimendan group
(
n
= 26)
Control group
(
n
= 23)
Gender (male/female)
22/4
19/4
Age (years)
50.15
±
13.42
54.43
±
13.22
Weight (kg)
75.70
±
14.16
71.80
±
7.20
Smoking history,
n
(%)
9 (34.6)
8 (34.8)
Drinking history,
n
(%)
8 (30.8)
6 (26.1)
Hypertension,
n
(%)
9 (34.6)
11 (47.8)
Diabetes,
n
(%)
5 (19.2)
7 (30.4)
Hyperlipidaemia,
n
(%)
7 (26.9)
6 (26.1)
Coronary heart disease,
n
(%)
4 (15.4)
9 (39.1)
Dilated heart disease,
n
(%)
20 (76.9)
10 (43.5)
Other,
n
(%)
2 (7.7)
4 (17.4)
Table 2. Indicators of detection between the
two groups before the treatment
Variables
Levosimendan group
Control group
Heart rate (beats/min)
86.15
±
13.13
82.65
±
16.57
Systolic blood pressure (mmHg)
121.88
±
14.51
126.74
±
24.55
Diastolic blood pressure (mmHg)
80.42
±
11.91
83.74
±
14.94
NT-proBNP (pg/ml)
4715.60
±
6881.17 4380.39
±
4350.10
Potassium (mmol/l)
4.02
±
0.48
4.02
±
0.53
Haemoglobin (g/l)
146.65
±
10.93
140.35
±
14.02
Haematocrit (%)
45.06
±
4.32
42.68
±
4.07
Creatinine (μmol/l)
81.64
±
24.56
85.66
±
22.02
NYHA III,
n
(%)
14 (53.8)
12 (52.2)
NYHA IV,
n
(%)
12 (46.2)
11 (47.8)
LVEF (%)
30.24
±
7.19
33.35
±
4.66
LVEDD (mm)
70.31
±
7.86
66.22
±
6.61
NYHA, New York Heart Association classification; LVEF, left ventricular ejec-
tion fraction; LVEDD, left ventricular end-diastolic diameter.