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

January 4, 2024 updated by: Yi Han
  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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • Recruiting
        • First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse outcome events
Time Frame: 30-days
Adverse outcome events (within 30 days) included mortality, unplanned readmission, transfer to ICU, and resuscitation.
30-days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse reactions
Time Frame: 30-days
Incidence of adverse reactions, including headache, hypotension, and cardiac arrhythmias.
30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi Han

Collaborators

Qianfoshan Hospital

Investigators

  • Principal Investigator: Yi Han, doctorate, First Affiliated Hospital of Shandon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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