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Search / Trial NCT06205758

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

Acute And Advanced Heart Failure Milrinone Levosimendan Renal Insufficiency

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.

Locations

Jinan, Shandong, China

Patients applied

0 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