Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency

Yi Han

Status: Enrolling

Conditions: Levosimendan; Efficacy; Milrinone; Heart Failure; Safety

Study type: Observational

Funder types: Other

Identifiers

NCT06205758

LM001

Details and patient eligibility

About

1. To evaluate the efficacy and safety of levosimendan and milrinone in the treatment of with acute heart failure with or without renal dysfunction;
2. Predictive modeling of the efficacy and safety of levosimendan and milrinone.

Full description

By comparing the safety and efficacy of milrinone with levosimendan as an initial inotropic agent for the treatment of patients with acute heart failure with or without abnormal renal function, a preliminary efficacy and safety prediction model was developed for levosimendan and milrinone based on the basic characteristics of the patients and the level of renal function.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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 or milrinone to maintain hemodynamic stability

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