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

Last updated: January 4, 2024
Sponsor: Yi Han
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Failure (Pediatric)

Hyponatremia

Nephropathy

Treatment

N/A

Clinical Study ID

NCT06205758
LM001
  • Ages 18-80
  • All Genders

Study Summary

  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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-80 years old
  • Patients who were clearly diagnosed with heart failure ( cardiac insufficiency ) andLVEF(Left Ventricular Ejection Fraction) < 50 %, and were judged by the physician toneed and agree to use levosimendan or milrinone to maintain hemodynamic stability

Exclusion

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 ), hypertrophicobstructive cardiomyopathy, ventricular assist device or surgical cardiac surgerywithin 30 days before the use of levosimendan
  • Patients with severe ventricular arrhythmia 1 within 24 hours before levosimendan andsystolic blood pressure 100 times / min within 2 hours before levosimendan
  • During hospitalization, other positive inotropic drugs 2 were used when levosimendanwas 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 peptideprecursor, serum total bilirubin, cardiac ultrasound baseline ( within 14 days beforeusing levosimendan ) data
  • pregnant and lactating women

Study Design

Total Participants: 1600
Study Start date:
November 16, 2023
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

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

    Jinan, Shandong 250014
    China

    Active - Recruiting

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