Clinical trial NCT05913271: 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Levosimendan
Efficacy
Safety
Keywords: Severe Heart Failure
Levosimendan
NAT2(N-acetyltransferase2) Gene Polymorphism
CrCl(Creatine clreance)
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
Collaborators: name: Qianfoshan Hospital
First posted: 2023-06-22
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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 %.

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.

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

Primary outcomes:
measure: 35-day survival rate
timeFrame: 35-day
Secondary outcomes:
measure: The changes of plasma BNP(brain natriuretic peptide） / NT-proBNP（N-terminal B-type natriuretic peptide） before and after treatment.
timeFrame: 35-day
measure: The improvement rate of patients ' health status
timeFrame: 35-day
measure: The incidence of composite endpoint events ( within 35 days ) included mortality, unplanned readmission, transfer to ICU, and rescue.
timeFrame: 35-day
Other outcomes:
measure: The incidence of adverse reactions, including headache, hypotension, arrhythmia.
timeFrame: 35-day
Locations:
city: Jinan
country: China
facility: First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
state: Shandong
Study officials:
affiliation: First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
name: Yi Han, doctorate
role: PRINCIPAL_INVESTIGATOR
References: