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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06205758
Other study ID # LM001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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