Effect of Carnitine on Uremic Cardiomyopathy

December 23, 2014 updated by: Masato Nishimura, MD, Toujinkai Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  1. Moderate or worse valvular heart disease,
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
No intervention
Experimental: Carnitine group
Intravenous administration of L-carnitine 1000mg after each hemodialysis session (three times a week) for one year.
Drug: Intravenous administration of L-carnitine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in BMIPP summed scores of the SPECT imaging
Time Frame: one year: September 2013-October 2014 (up to 2 years)
one year: September 2013-October 2014 (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toujinkai Hospital

Investigators

  • Principal Investigator: Masato Nishimura, MD, Toujinkai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Estimate)

December 25, 2014

Last Update Submitted That Met QC Criteria

December 23, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Dialysis heart carnitine study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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