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Effect of Carnitine on Uremic Cardiomyopathy

NCT ID: NCT02322697

Last Updated: 2014-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-10-31

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.

Conditions

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Disorder of Fatty Acid Metabolism

Keywords

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Carnitine hemodialysis fatty acid imaging heart

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carnitine group

Intravenous administration of L-carnitine 1000mg after each hemodialysis session (three times a week) for one year.

Group Type EXPERIMENTAL

Intravenous administration of L-carnitine

Intervention Type DRUG

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

control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intravenous administration of L-carnitine

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

Intervention Type DRUG

Other Intervention Names

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Chronic intravenous administration of L-carnitine

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

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Toujinkai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Masato Nishimura, MD

Director of cardiovascular division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Masato Nishimura, MD

Role: PRINCIPAL_INVESTIGATOR

Toujinkai Hospital

Other Identifiers

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Dialysis heart carnitine study

Identifier Type: -

Identifier Source: org_study_id