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

Sponsor

Yi Han (Other)

Overall Status

Recruiting

CT.gov ID

NCT05913271

Collaborator

Qianfoshan Hospital (Other)

352

Enrollment

Location

Anticipated Duration (Months)

14.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Levosimendan Efficacy Safety

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

352 participants

Observational Model:

Other

Time Perspective:

Other

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

Actual Study Start Date :

May 30, 2023

Anticipated Primary Completion Date :

May 30, 2025

Anticipated Study Completion Date :

May 30, 2025

Outcome Measures

Primary Outcome Measures

35-day survival rate [35-day]
Survival of patients at 35 days

Secondary Outcome Measures

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 Outcome Measures

The incidence of adverse reactions, including headache, hypotension, arrhythmia. [35-day]
Adverse reactions after medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )	Jinan	Shandong	China	250014

Sponsors and Collaborators

Yi Han
Qianfoshan Hospital

Investigators

Principal Investigator: Yi Han, doctorate, First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )