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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205758
• Other study ID #: LM001
• Status: Recruiting
• Start date: November 16, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2024
• Source: Qianfoshan Hospital
• Contact: Yi Han, doctorate
• Phone: 15552565120
• Email: 15552565120[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Efficacy
• Heart Failure
• Renal Insufficiency
• Safety

Locations

Country	Name	City	State
China	First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Yi Han	Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse reactions	Incidence of adverse reactions, including headache, hypotension, and cardiac arrhythmias.	30-days
Primary	Adverse outcome events	Adverse outcome events (within 30 days) included mortality, unplanned readmission, transfer to ICU, and resuscitation.	30-days