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

NCT ID: NCT05913271

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 352 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2025-05-30

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.

Conditions

Heart Failure; Levosimendan; Efficacy; Safety

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: collaborator

Yi Han

OTHER

Sponsor Role: lead

Responsible Party

Yi Han

Associate professor of pharmacy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yi Han, doctorate

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )

Locations

First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Han, doctorate

Role: CONTACT

15552565120@163.com

15552565120

Facility Contacts

Yi Han, doctorate

Role: primary

15552565120@163.com

15552565120

Other Identifiers

LNAT

Identifier Type: -

Identifier Source: org_study_id