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OpenTrials
Completed

NCT Number: NCT02322697

Effect of Carnitine on Uremic Cardiomyopathy

Patients on chronic hemodialysis without obstructive coronary artery disease identified by coronary angiography were randomly divided into the two groups: carnitine group and control group. SPECT using FFA analogue, BMIPP, was performed before and one year after intravenous administration of L-carnitine (1000 mg on every dialysis session). Control group received the examination of BMIPP SPECT at the same time of the carnitine group. The effects of chronic intravenous administration of L-carnitine on myocardial fatty acid metabolism were investigated among this population.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients on chronic hemodialysis in Toujinkai hospital who had no obstructive coronary artery disease identified by coronary angiography and left ventricular dysfunction were randomly divided into the two groups: carnitine group and control group. To evaluate the possible effect of carnitine administration on myocardial fatty acid metabolism, SPECT using FFA analogue, BMIPP, was performed before and one year after intravenous administration of L-carnitine (1000 mg on every dialysis session). Control group received the examination of BMIPP SPECT at the same time of the carnitine group. Circulating concentrations of total, free, and acyl L-carnitine were measured every three months in the carnitine group. Clinical data including blood chemistry, blood pressure, or cardiac functions by echocardiography were obtained every 6 months in both groups. The effects of chronic intravenous administration of L-carnitine on myocardial fatty acid metabolism and cardiac functions were investigated among this population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients on chronic hemodialysis without significant obstructive coronary artery disease identified by angiography within one years of the study, and who had left ventricular dysfunction:
  • reduced left ventricular systolic function (left ventricular ejection fraction <55%) and/or
  • left ventricular hypertrophy evaluated by echocardiography)

Exclusion criteria

  • Moderate or worse valvular heart disease,
  • Past histories of acute or old myocardial infarction and/or coronary revascularization by percutaneous coronary intervention or coronary artery bypass grafting within one year of the study.

Treatment and study plan

Intravenous administration of L-carnitine

Drug

Chronic intravenous administration of L-carnitine (1000mg on each dialysis session) for 1 year in hemodialysis patients

Other names: Chronic intravenous administration of L-carnitine

Primary outcomes

  1. changes in BMIPP summed scores of the SPECT imaging

    Time frame: one year: September 2013-October 2014 (up to 2 years)

Sponsors and collaborators

Lead sponsor

Toujinkai Hospital

Other

Registry information

Official study title

Effects of Chronic Intravenous Administration of L-carnitine on Myocardial Fatty Acid Metabolism in Hemodialysis Patients

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2014
Registry last updated
Dec 25, 2014

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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