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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heart Failure, Levosimendan, Efficacy, Safety

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 35-day survival rate | Survival of patients at 35 days | 35-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of plasma BNP(brain natriuretic peptide） / NT-proBNP（N-terminal B-type natriuretic peptide） before and after treatment. | Measurement of BNP（brain natriuretic peptide） / NT-proBNP（N-terminal B-type natriuretic peptide） | 35-day | 
| The improvement rate of patients ' health status | EQ-5D scale(EuroQol Five Dimensions Questionnaire) was used to assess health status | 35-day | 
| The incidence of composite endpoint events ( within 35 days ) included mortality, unplanned readmission, transfer to ICU, and rescue. | Incidence of composite endpoint events within 35 days | 35-day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Heart Failure, Levosimendan, NAT2(N-acetyltransferase2) Gene Polymorphism, CrCl(Creatine clreance)