Brief Title
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
Official Title
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
Brief Summary
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
Detailed Description
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
The change of NT-proBNP level
Secondary Outcome
The change of CK-MB
Condition
Aortic Valve Stenosis
Intervention
Levosimendan
Study Arms / Comparison Groups
Levosimendan
Description: Levosimendan 0.1µg/kg/min will last for 24h after the valve is released.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
124
Start Date
September 1, 2020
Completion Date
December 30, 2022
Primary Completion Date
April 1, 2022
Eligibility Criteria
Inclusion Criteria:
1. 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
2. Severe aortic stenosis
1. Mean transaortic gradient ≥ 40 mmHg(at rest or stress)
2. Aortic peak velocity ≥ 4m/s;
3. Arotic valve area <0.8 cm2 and/or aortic valve area index< 0.5cm2/m2
3. Cardiac dysfunction
1. LVEF≤50% (estimated by Simpson)
2. NT-proBNP≥1500ng/L；
3. Symptoms of dyspnea and fatigue when at rest or after slight exertion (New York
Heart Association ≥ Ⅲ -Ⅳ)
4. Intermittant fluid retention and/or symptoms induced by low cardiac output at
rest, but lack of hemodynamic instability
Exclusion Criteria:
1. Decompensated acute cardiac failure due to hemodynamic instability
2. A historty of torsade de points ventricular tachycardia
3. Known allergic reaction or sensitivity to Levosimendan or excipients
4. Received levosimendan within 1 week prior to the planned clinical trial
5. Serum potassium < 3.5 mmol/L and > 5.5 mmol/L before the drug study
6. Systolic blood pressure < 90mmHg at baseline
7. Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2.
8. Unable to participate in study for being critically ill asssed by clinicians
9. 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.
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
, 010-88398082, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04573049
Organization ID
2020-1357
Responsible Party
Principal Investigator
Study Sponsor
China National Center for Cardiovascular Diseases
Collaborators
China International Medical Foundation
Study Sponsor
, ,
Verification Date
September 2020