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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04573049
Other study ID # 2020-1357
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date December 30, 2022

Study information

Verified date September 2020
Source China National Center for Cardiovascular Diseases
Contact Jianhui Wang, MD
Phone 010-88398082
Email stewenwang@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 124
Est. completion date December 30, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 = ? -?)

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Levosimendan
On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min levosimendan is given for 24 hours.
Other:
Placebo
On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min 5% glucose infusion is given for 24 hours.

Locations

Country Name City State
China Jianhui Wang Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
China National Center for Cardiovascular Diseases China International Medical Foundation

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other The incidence of adverse events Adverse events include hypotension and arrythmia. Peri-operation
Other The incidence of atrial fibrillation Peri-operation
Other The change of electrolyte The change of electrolyte is evaluated by potassium, calcium and lactic acid level. Peri-operation
Other The number of patients having liver dysfunction Liver dysfunction is assessed by the change of alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Peri-operation
Other The length of intensive care unit stay From date of surgery until intensive care unit discharge (assessed up to 1 month)
Other In-hospital medical expense From baseline until hospital discharge (assessed up to 1 month)
Primary The change of NT-proBNP level day 1, day 3, day 5, month 1 and month 3
Secondary The change of CK-MB day 1, day 3, day 5, month 1 and month 3
Secondary The change of c-TnI day 1, day 3, day 5, month 1 and month 3
Secondary The change of left ventricular ejection fraction It is evaluated by echcardiography. day 1, day 3, day 5, month 1 and month 3
Secondary The change of left ventricular end-diastolic diameter It is evaluated by echcardiography. day 1, day 3, day 5, month 1 and month 3
Secondary The number of patients in need of secondary intra-operative vasoactive-inotropic substances Vasoactive-inotropic substances include dobutamine, milrinone, epinephrine, dopamine and vasopressors. Peri-operation
Secondary The incidence of postoperative kidney injury The kidney injury will be assessed by the change of serum creatinine, urea nitrogen and cystatin C. day 1, day 3, day 5, month 1 and month 3
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