Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients

Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients: A Multicenter, Prospective, Non-randomized, Controlled Real-world Study

This study is intended to be a multicenter, prospective, non-randomized, controlled real-world study. Patients receiving L-carnitine injection were included in the experimental group and the control group according to whether they received L-carnitine injection. Patients receiving L-carnitine injection were included in the experimental group, and those receiving L-carnitine injection were included in the control group.To observe the effects of L-carnitine on cardiac function in hemodialysis patients.

Study Overview

• Status: Completed
• Conditions: Renal Dialysis
• Intervention / Treatment: Drug: Levocarnitine Injection

• Study Type: Interventional
• Enrollment (Actual): 1008
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital of Zhejiang Chinese Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Maintenance hemodialysis patients;
• 18 years<80 years;
• Have clear consciousness and independent behavior ability;
• Before dialysis, the total carnitine concentration was less than 40 umol/L, or the free carnitine concentration was less than 35 umol/L.

Exclusion Criteria:

• Acute cardiovascular and cerebrovascular diseases occurred within 1 month;
• Infectious diseases occurred within 1 month; Treatment with glucocorticoid or immunosuppressant;
• Patients who have used L-carnitine within 2 weeks.
• Hematological system tumor or tumor;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; The patients in the test group were injected with levocarnitine on each dialysis day, and other conventional treatment drugs such as hemodialysis drugs were maintained in the original scheme and recorded in detail on the CRF form.	Drug: Levocarnitine Injection; The patients in the test group were injected with 1-2g (10-20mg/kg) levocarnitine on each dialysis day
No Intervention: Control group; The patients in the control group were the same as those in the test group, except that they were not treated with L-carnitine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Left ventricular ejection fraction	baseline and week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Brain natriuretic peptide level	baseline ,week 4 and week 12
Change from baseline in left ventricular short axis shortening rate	baseline and week 12
Change from baseline in stroke volume	baseline and week 12
Change from baseline in the ratio of peak E to peak A of mitral valve blood flow velocity in early and late diastolic periods	baseline and week 12
Change from baseline in serum albumin	baseline and week 12
Change from baseline in upper arm circumference	baseline and week 12
Change from baseline in prealbumin	baseline and week 12
Change from baseline in hemoglobin	baseline and week 12

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 3, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: prospective; multicenter; Renal Dialysis; real-world study; controlled; non-randomized; Cardiac Function Tests
• Other Study ID Numbers: 2022-ZKNT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No