Effect of Carnitine on Uremic Cardiomyopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Disorder of Fatty Acid Metabolism

Intervention / Treatment
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* Drug: Intravenous administration of L-carnitine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carnitine group<br>Intravenous administration of L-carnitine 1000mg after each hemodialysis session (three times a week) for one year. | Drug: Intravenous administration of L-carnitine<br>* Chronic intravenous administration of L-carnitine (1000mg on each dialysis session) for 1 year in hemodialysis patients<br>* Other names: Chronic intravenous administration of L-carnitine;|
| No Intervention: control group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carnitine, hemodialysis, fatty acid, imaging, heart