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

NCT05913271 | Unknown DMC

• 1 other identifier: LNAT
• Study Type: observational
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the efficacy and safety of levosimendan in the treatment of heart failure ;
2. 2.Guide patients to apply levosimendan individually and establish a dose adjustment program.

Conditions

Heart Failure; Levosimendan; Efficacy; Safety

Keywords

Severe Heart Failure; Levosimendan; NAT2(N-acetyltransferase2) Gene Polymorphism; CrCl(Creatine clreance)

Outcome Measures

Primary Outcomes (1)

• 35-day survival rate

  Survival of patients at 35 days

  35-day

Secondary Outcomes (3)

• The changes of plasma BNP(brain natriuretic peptide） / NT-proBNP（N-terminal B-type natriuretic peptide） before and after treatment.

  35-day

• The improvement rate of patients ' health status

  35-day

• The incidence of composite endpoint events ( within 35 days ) included mortality, unplanned readmission, transfer to ICU, and rescue.

  35-day

Other Outcomes (1)

• The incidence of adverse reactions, including headache, hypotension, arrhythmia.

  35-day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 %.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yi Han: lead
• Qianfoshan Hospital: collaborator

Study Sites (1)

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

Jinan, Shandong, 250014, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Yi Han, doctorate

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Han, doctorate

CONTACT

15552565120; 15552565120@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 35 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor of pharmacy

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 22, 2023
• Study Start: May 30, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)