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

Phase 4

Completed

• Conditions: Renal Dialysis
• Interventions: Drug: Levocarnitine Injection

• Registration Number: NCT05673239
• Lead Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-29
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-06
• Study Start: 2023-01-15
• Primary Completion: 2023-06-30
• Study Completion: 2024-06-30
• Last Update Submitted: 2024-08-03
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1008

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Levocarnitine Injection	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Left ventricular ejection fraction	baseline and week 12

Secondary Outcome Measures

Name	Time	Method
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 upper arm circumference	baseline and week 12
Change from baseline in Brain natriuretic peptide level	baseline ,week 4 and week 12
Change from baseline in prealbumin	baseline and week 12
Change from baseline in serum albumin	baseline and week 12
Change from baseline in left ventricular short axis shortening rate	baseline and week 12
Change from baseline in hemoglobin	baseline and week 12

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China