Heart Failure Clinical Trial
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
NCT number | NCT06205758 |
Other study ID # | LM001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 16, 2023 |
Est. completion date | June 1, 2025 |
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.
Status | Recruiting |
Enrollment | 1600 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province ) | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Yi Han | Qianfoshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of adverse reactions | Incidence of adverse reactions, including headache, hypotension, and cardiac arrhythmias. | 30-days | |
Primary | Adverse outcome events | Adverse outcome events (within 30 days) included mortality, unplanned readmission, transfer to ICU, and resuscitation. | 30-days |
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