The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement

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    China National Center for Cardiovascular Diseases
Updated on 26 January 2021
heart failure
aortic valve replacement


A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement


The number of subjects undergoing transcatheter aortic valve replacement to treat aortic stenosis have been increasing in recent decades. Levosimendan, an innovative inotrope, is powerfully evidenced to have the function to improve cardiac output and hemodynamic parameters. However, there is no specified study concentrated on the role of Levosimendan in surgical procedure such as transcathter aortic intervention. This double-blind, randomized, placebo-controlled study is aimed to investigate the effectiveness and safety of Levosimendan in adults having severe aortic stenosis combined with heart failure undergoing transcatheter aortic valve replacement. Therefore, the purpose of this trial is to explore whether the improvement of cardiac and renal performance can be rendered by intra-operative Levosimendan infusion.

Condition Aortic Stenosis, Heart failure, Congestive Heart Failure, Heart failure, Heart disease, Heart disease, Cardiac Disease, VALVULAR HEART DISEASE, Heart Valve Disease, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, Safety Issues, Cardiac Event, TAVI, Congestive Heart Failure, Heart Valve Disease, Cardiac Disease, Effect of Drug, Inotropic Agents, aortic valve stenosis, cardiac events, transcatheter aortic valve implant, inotropes, inotropic agent, cardiac failure, congestive heart disease
Treatment Placebo, Levosimendan
Clinical Study IdentifierNCT04573049
SponsorChina National Center for Cardiovascular Diseases
Last Modified on26 January 2021


Yes No Not Sure

Inclusion Criteria

Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Severe aortic stenosis
Mean transaortic gradient 40 mmHg(at rest or stress)
Aortic peak velocity 4m/s
Arotic valve area <0.8 cm2 and/or aortic valve area index< 0.5cm2/m2
Cardiac dysfunction
LVEF50% (estimated by Simpson)
Symptoms of dyspnea and fatigue when at rest or after slight exertion (New York Heart Association -)
Intermittant fluid retention and/or symptoms induced by low cardiac output at rest, but lack of hemodynamic instability

Exclusion Criteria

Decompensated acute cardiac failure due to hemodynamic instability
A historty of torsade de points ventricular tachycardia
Known allergic reaction or sensitivity to Levosimendan or excipients
Received levosimendan within 1 week prior to the planned clinical trial
Serum potassium < 3.5 mmol/L and > 5.5 mmol/L before the drug study
Systolic blood pressure < 90mmHg at baseline
Estimated glomerular filtration rate (eGFR) 30 mL/min/1.73m2
Unable to participate in study for being critically ill asssed by clinicians
Other concomitant severe morbidities leading to poor prognosis and decreased mortality, such as malignant tumor and disease involving other vital organs; life expectancy less than 1 year
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