Last updated: January 4, 2024
Sponsor: Yi Han
Overall Status: Active - Recruiting
Phase
N/A
Condition
Kidney Failure (Pediatric)
Hyponatremia
Nephropathy
Treatment
N/AClinical Study ID
NCT06205758
LM001
Ages 18-80 All Genders
Study Summary
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
Connect with a study center
First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
Jinan, Shandong 250014
ChinaActive - Recruiting
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