Heart Failure Clinical Trial
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
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
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. |
Country | Name | City | State |
---|---|---|---|
China | Jianhui Wang | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
China National Center for Cardiovascular Diseases | China International Medical Foundation |
China,
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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