Status:
RECRUITING
Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency
Lead Sponsor:
Yi Han
Collaborating Sponsors:
Qianfoshan Hospital
Conditions:
Heart Failure
Levosimendan
Eligibility:
All Genders
18-80 years
Brief 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 o...
Detailed 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 prel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT06205758
Start Date
November 16 2023
End Date
June 1 2025
Last Update
January 16 2024
Active Locations (1)
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1
First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
Jinan, Shandong, China, 250014