Systolic Heart Failure Clinical Trial
Official title:
Effectiveness of a Repetitive Use of 24-hour Levosimendan Infusions in Patients With Severe Systolic Heart Failure in Order to Prevent Rehospitalizations
Rehospitalizations due to exacerbation of chronic heart failure are an important problem for
patients suffering from heart failure.
Rehospitalzations lead to worse prognosis, have an impact on the quality of life and have a
negative financial impact on the health care system.
Currently, studies are being conducted on the efficacy of levosimendan in the prevention of
heart failure exacerbations. Patients receive levosimendan at repetitive use and preliminary
results suggest a reduction in the incidence of exacerbations of heart failure.
Thanks to the clinical trial planned in the Department of Cardiology of the Biziel Hospital
with repeatable use of levosimendan, it is possible to determine the benefits of this method
of treatment more accurately.
Heart failure affects 12% of the adult population and its frequency increases with age and
affects 10% of people over 70 years old. Heart failure is characterized by high annual death
rate reaching 17% and the percentage of rehospitalization at the level of 44% annually. In
order to reduce morbidity and mortality rates in the case of heart failure, many diagnostic
and therapeutic methods have been introduced over the last few years, however the prognosis
for this medical condition is still unfavorable nonetheless.
Rehospitalizations due to exacerbation of chronic heart failure are an important problem for
patients suffering from heart failure.
Rehospitalzations lead to worse prognosis, have an impact on the quality of life and have a
negative financial impact on the health care system. At the moment, there are numerous
clinical trials aimed at improving the prognosis of patients with heart failure.
Levosimendan is a modern drug registered in the treatment of acute heart failure. In the
current ESC guidelines for the treatment of patients with acute heart failure, levosimendan
is mainly recommended for the group of patients chronically treated with beta-adrenolytics
and in the treatment of a peri-infarction shock.
It is a substance with inotropic positive and vasodilating effects. It belongs to the group
of drugs sensitizing contractile elements of a myocardium on calcium ions. In the clinical
trials and meta-analyses, the safety profile of levosimendan is better in comparison to the
classical pressure amines used in the treatment of acute heart failure: dobutamine and
dopamine. Beneficial clinical effect of levosimendan is prolonged beyond the period of its
direct use due to the active metabolites remaining in the bloodstream.
Currently, studies are being conducted on the efficacy of levosimendan in the prevention of
heart failure exacerbations. Patients receive levosimendan at repetitive use and preliminary
results suggest a reduction in the incidence of exacerbations of heart failure. Due to the
low number of patients included in individual centers and non-homogeneous protocols of the
use of levosimendan in repeated infusions, the benefits of using this method of treatment can
not be clearly determined at present. Thanks to the clinical trial planned in the Department
of Cardiology of the Biziel Hospital with repeatable use of levosimendan, it is possible to
determine the benefits of this method of treatment more accurately.
Levosimendan is a drug with a beneficial safety profile, and the most common side effect,
which is hypotension, will disappear shortly after discontinuation of treatment or after an
infusion of crystalloids. Patients will be hospitalized at ITK, where a standard physical
examination will be conducted. The patient will fill in the SF36 questionnaire before the
treatment to self-evaluate his or hers quality of life. The patient will take medication
according to the latest outpatient recommendations.
During the 24-hour treatment, blood pressure will be monitored (until the target dose is
set). The heart rate will be monitored continuously (for the next 2 hours every 30 minutes,
then every 1 hour). Daily balance of fluids will be administered.
The patient will initially receive a standard dose of 0.1 mcg/kgmc/min. In case of good
tolerance of the drug - the dose will be increased to 0.2 mcg/kgmc/min. If hypotension SBP
<90 mmHg occurs, the dose will be reduced to 0.05 mcg / kgm / min. If the hypotension
persists despite the reduction of the drug - the infusion will be terminated and the patient
will be excluded from the study. The infusion will be terminated within 24 hours, the patient
will be examined again 4 hours after the end of the infusion, by the attending physician and
unless there are contraindications - discharged home.
Patients will be hospitalized every 4 weeks for the next 6 months with the above-mentioned
parameters from the peripheral blood and march test, before the next dose. The control test
will also include the determination of the concentration of levosimendan metabolites prior to
the next infusion.
During the last follow-up visit, echocardiography and spiroergometry testing will be
performed before the next dosage.
After the 12 months of inclusion in the study, a telephone interview will be conducted in the
direction of rehospitalization due to exacerbation of heart failure.
The data obtained from the study will be compared with the standard parameters of
rehospitalization due to the exacerbation of heart failure included in the ESC guidelines.
The variability of data obtained from the quality of life questionnaire at the beginning and
at the end of the study will also be evaluated.
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