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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913271
• Other study ID #: LNAT
• Status: Recruiting
• Start date: May 30, 2023
• Est. completion date: May 30, 2025

Study information

• Verified date: June 2023
• Source: Qianfoshan Hospital
• Contact: Yi Han, doctorate
• Phone: 15552565120
• Email: 15552565120[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Efficacy
• Heart Failure
• Safety

Locations

Country	Name	City	State
China	First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Yi Han	Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of adverse reactions, including headache, hypotension, arrhythmia.	Adverse reactions after medication	35-day
Primary	35-day survival rate	Survival of patients at 35 days	35-day
Secondary	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
Secondary	The improvement rate of patients ' health status	EQ-5D scale(EuroQol Five Dimensions Questionnaire) was used to assess health status	35-day
Secondary	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