NCT05913271RecruitingNot Applicable
Study on the Correlation Between NAT2(N-acetyltransferase2) Gene Polymorphism and CrCl(Creatine Clreance) and the Efficacy and Safety of Levosimendan in Patients With Severe Heart Failure
Yi Han1 site in 1 country352 target enrollmentStarted: May 30, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 352
- Locations
- 1
- Primary Endpoint
- 35-day survival rate
Study Overview
Brief Summary
- To evaluate the efficacy and safety of levosimendan in the treatment of heart failure ;
- Guide patients to apply levosimendan individually and establish a dose adjustment program.
Detailed Description
The efficacy and safety of levosimendan in Chinese patients with different acetylmetabolites and CrCl(Creatine clreance) were re-evaluated after marketing. The population pharmacokinetics of different populations was studied, and the patients were guided to apply levosimendan individually and establish a dose adjustment program.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-80 years old
- •Patients who were clearly diagnosed with heart failure ( cardiac insufficiency ) and LVEF(Left Ventricular Ejection Fraction) < 50 %, and were judged by the physician to need and agree to use levosimendan to maintain hemodynamic stability
- •Sign informed consent
Exclusion Criteria
- •chronic heart failure and New York Heart Association ( NYHA ) class I ~ II
- •Complicated with infective endocarditis, aortic dissection, severe liver dysfunction ( child-pugh C ), severe renal insufficiency ( CrCl < 30 ml / min ), hypertrophic obstructive cardiomyopathy, ventricular assist device or surgical cardiac surgery within 30 days before the use of levosimendan
- •Patients with severe ventricular arrhythmia 1 within 24 hours before levosimendan and systolic blood pressure 100 times / min within 2 hours before levosimendan
- •During hospitalization, other positive inotropic drugs 2 were used when levosimendan was intravenously pumped or dripped, excluding the use of catecholamines for rescue
- •received positive inotropic drug 2 treatment in the last 30 days
- •Lack of serum creatinine, brain natriuretic peptide or brain natriuretic peptide precursor, serum total bilirubin, cardiac ultrasound baseline ( within 14 days before using levosimendan ) data
- •pregnant and lactating women
Outcomes
Primary Outcomes
35-day survival rate
Time Frame: 35-day
Survival of patients at 35 days
Secondary Outcomes
- The changes of plasma BNP(brain natriuretic peptide） / NT-proBNP（N-terminal B-type natriuretic peptide） before and after treatment.(35-day)
- The improvement rate of patients ' health status(35-day)
- The incidence of composite endpoint events ( within 35 days ) included mortality, unplanned readmission, transfer to ICU, and rescue.(35-day)
Investigators
Yi Han
Associate professor of pharmacy
Qianfoshan Hospital
Study Sites (1)
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