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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Efficacy; Safety; Levosimendan

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 Type: Observational
• Enrollment (Estimated): 352

Contacts and Locations

• Study Contact: Name: Yi Han, doctorate; Phone Number: 15552565120; Email: 15552565120@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
      • Contact: Yi Han, doctorate; Phone Number: 15552565120; Email: 15552565120@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Severe heart failure generally refers to the low perfusion of tissues and organs caused by acute heart failure and acute exacerbation of chronic cardiac insufficiency, which seriously affects life. It is often combined with multiple organs, especially renal function injury. Its prognosis is poor, mortality and readmission rate are high, and the 1-year mortality rate can reach more than 20 %.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
35-day survival rate	Survival of patients at 35 days	35-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The improvement rate of patients ' health status	EQ-5D scale(EuroQol Five Dimensions Questionnaire) was used to assess health status	35-day
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse reactions, including headache, hypotension, arrhythmia.	Adverse reactions after medication	35-day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 17, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Levosimendan; Severe Heart Failure; NAT2(N-acetyltransferase2) Gene Polymorphism; CrCl(Creatine clreance)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: LNAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No