Efficacy, Heart Failure, Levosimendan, Safety
Conditions
Keywords
Severe Heart Failure, Levosimendan, NAT2(N-acetyltransferase2) Gene Polymorphism, CrCl(Creatine clreance)
Brief summary
1. To evaluate the efficacy and safety of levosimendan in the treatment of heart failure ; 2. 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.
Interventions
None listed
Sponsors
Qianfoshan Hospital
Yi Han
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 35-day survival rate | 35-day | Survival of patients at 35 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes of plasma BNP(brain natriuretic peptide） / NT-proBNP（N-terminal B-type natriuretic peptide） before and after treatment. | 35-day | Measurement of BNP（brain natriuretic peptide） / NT-proBNP（N-terminal B-type natriuretic peptide） |
| The improvement rate of patients ' health status | 35-day | EQ-5D scale(EuroQol Five Dimensions Questionnaire) was used to assess health status |
| The incidence of composite endpoint events ( within 35 days ) included mortality, unplanned readmission, transfer to ICU, and rescue. | 35-day | Incidence of composite endpoint events within 35 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| The incidence of adverse reactions, including headache, hypotension, arrhythmia. | 35-day | Adverse reactions after medication |
Countries
China
Contacts
Primary ContactYi Han, doctorate
Outcome results
None listed