Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency
Launched by YI HAN · Jan 4, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two medications, levosimendan and milrinone, to see how effective and safe they are for treating patients with acute heart failure, especially those who may also have kidney problems. The goal is to find out which of these drugs works better for helping the heart pump blood effectively while keeping patients stable.
To participate in this trial, individuals need to be between 18 and 80 years old and have been diagnosed with heart failure, meaning their heart isn't pumping as well as it should be. Specifically, they should have a measurement called Left Ventricular Ejection Fraction (LVEF) of less than 50%. Some people may not qualify, such as those with certain serious heart conditions or severe kidney issues. If eligible, participants will receive either levosimendan or milrinone and will be monitored closely to track their health and how well the medications work. This trial is currently recruiting participants, and it aims to provide valuable insights into the best treatment options for those suffering from heart failure.
Gender
ALL
Eligibility criteria
- 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
About Yi Han
Yi Han is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a focus on rigorous scientific methodology and ethical standards, Yi Han collaborates with leading researchers and institutions to design and implement clinical trials across various therapeutic areas. The organization prioritizes patient safety and data integrity, leveraging cutting-edge technology and robust analytics to ensure the efficacy of its investigational products. By fostering a culture of collaboration and transparency, Yi Han strives to contribute significantly to the healthcare landscape and bring forth transformative treatments for patients in need.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jinan, Shandong, China
Patients applied
Trial Officials
Yi Han, doctorate
Principal Investigator
First Affiliated Hospital of Shandon
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported