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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06205758
Enrollment
1600
Registered
2024-01-16
Start date
2023-11-16
Completion date
2025-06-01
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy, Heart Failure, Levosimendan, Milrinone, Safety

Keywords

Acute and advanced heart failure, Milrinone, Levosimendan, renal insufficiency

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.

Interventions

None listed

Sponsors

Qianfoshan Hospital
CollaboratorOTHER
Yi Han
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adverse outcome events30-daysAdverse outcome events (within 30 days) included mortality, unplanned readmission, transfer to ICU, and resuscitation.

Other

MeasureTime frameDescription
Incidence of adverse reactions30-daysIncidence of adverse reactions, including headache, hypotension, and cardiac arrhythmias.

Countries

China

Contacts

Primary ContactYi Han, doctorate
15552565120@163.com15552565120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026