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Completed

NCT Number: NCT05673239

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

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.

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Key information

Conditions

Renal Dialysis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Levocarnitine Injection

Drug

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

Primary outcomes

  1. Change from baseline in Left ventricular ejection fraction

    Time frame: baseline and week 12

Secondary outcomes

  1. Change from baseline in Brain natriuretic peptide level

    Time frame: baseline ,week 4 and week 12

  2. Change from baseline in left ventricular short axis shortening rate

    Time frame: baseline and week 12

  3. Change from baseline in stroke volume

    Time frame: baseline and week 12

  4. Change from baseline in the ratio of peak E to peak A of mitral valve blood flow velocity in early and late diastolic periods

    Time frame: baseline and week 12

  5. Change from baseline in serum albumin

    Time frame: baseline and week 12

  6. Change from baseline in upper arm circumference

    Time frame: baseline and week 12

  7. Change from baseline in prealbumin

    Time frame: baseline and week 12

  8. Change from baseline in hemoglobin

    Time frame: baseline and week 12

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 6, 2023
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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