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

NCT06205758 | Unknown DMC

• 1 other identifier: LM001
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Predictive modeling of the efficacy and safety of levosimendan and milrinone.

Conditions

Heart Failure; Levosimendan; Milrinone; Efficacy; Safety

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Adverse outcome events

  Adverse outcome events (within 30 days) included mortality, unplanned readmission, transfer to ICU, and resuscitation.

  30-days

Other Outcomes (1)

• Incidence of adverse reactions

  30-days

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yi Han: lead
• Qianfoshan Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yi Han, doctorate

  First Affiliated Hospital of Shandon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Han, doctorate

CONTACT

15552565120; 15552565120@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor of pharmacy

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: November 16, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

CN (1)