Comparing milrinone and levosimendan for treating heart failure with kidney issues

Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency

This study is testing whether milrinone or levosimendan works better and is safer for people with heart failure who also have kidney problems.

Quick facts

• Study type: Observational
• Enrollment: 1600 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06205758 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of two inotropic drugs, milrinone and levosimendan, in patients suffering from acute heart failure, particularly those with renal insufficiency. It aims to develop a predictive model based on patient characteristics and renal function to determine which drug may be more effective and safer for individual patients. The study involves observational data collection from patients who meet specific criteria regarding their heart failure diagnosis and renal function. By analyzing this data, researchers hope to provide insights into optimal treatment strategies for this vulnerable patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 diagnosed with heart failure and a left ventricular ejection fraction of less than 50% who require inotropic support.

Not a fit: Patients with chronic heart failure classified as NYHA class I or II, or those with severe renal insufficiency or other significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with acute heart failure and renal insufficiency.

How similar studies have performed: Other studies have explored the use of inotropic agents in heart failure, but this specific comparison and predictive modeling approach is relatively novel.

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

Where this trial is running

Jinan, Shandong

• First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province ) — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Yi Han, doctorate — First Affiliated Hospital of Shandon
• Study coordinator: Yi Han, doctorate

Conditions Heart Failure; Levosimendan; Milrinone; Efficacy; Safety; Acute and advanced heart failure; renal insufficiency