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

Recruiting

• Conditions: Efficacy; Safety; Heart Failure; Levosimendan

• Registration Number: NCT05913271
• Lead Sponsor: Yi Han

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.

Study Timeline

• Study Start: 2023-05-30
• Status Verified: 2023-06
• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-17
• Last Update Submitted: 2023-06-17
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 352

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
35-day survival rate	35-day	Survival of patients at 35 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province ); 🇨🇳 Jinan, Shandong, China