Clinical 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
Official title: Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Levosimendan
Milrinone
Efficacy
Safety
Keywords: Acute and advanced heart failure
Milrinone
Levosimendan
renal insufficiency
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
Collaborators: name: Qianfoshan Hospital
First posted: 2024-01-16
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute heart failure (AHF), including new-onset acute heart failure AHF and acute decompensated chronic heart failure (ADHF), is usually associated with either mild or severe renal impairment. Deterioration of renal function can lead to a serious prognosis. Milrinone and levosimendan are the most commonly prescribed inotropic drugs with preclinical and clinical evidence of their renoprotective effects.

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Adverse outcome events
timeFrame: 30-days
Secondary outcomes:
Other outcomes:
measure: Incidence of adverse reactions
timeFrame: 30-days
Locations:
city: Jinan
country: China
facility: First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
state: Shandong
Study officials:
affiliation: First Affiliated Hospital of Shandon
name: Yi Han, doctorate
role: PRINCIPAL_INVESTIGATOR
References: