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

NCT05673239 | Completed Phase 4

• 1 other identifier: 2022-ZKNT-001
• Study Type: interventional
• Target: 1,008
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Dialysis

Keywords

Renal Dialysis; Cardiac Function Tests; real-world study; multicenter; prospective; non-randomized; controlled

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Left ventricular ejection fraction

  baseline and week 12

Secondary Outcomes (8)

• 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

Study Arms (2)

Test group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The patients in the control group were the same as those in the test group, except that they were not treated with L-carnitine.

Interventions

Levocarnitine Injection DRUG

The patients in the test group were injected with 1-2g (10-20mg/kg) levocarnitine on each dialysis day

Test group

Eligibility Criteria

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

You may qualify if:

• Maintenance hemodialysis patients;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Carnitine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: January 6, 2023
• Study Start: January 15, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: August 6, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)