Effect of Carnitine on Uremic Cardiomyopathy

NCT02322697 | Completed

• 1 other identifier: Dialysis heart carnitine study
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Disorder of Fatty Acid Metabolism

Keywords

Carnitine; hemodialysis; fatty acid; imaging; heart

Outcome Measures

Primary Outcomes (1)

• changes in BMIPP summed scores of the SPECT imaging

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

Study Arms (2)

Carnitine group

EXPERIMENTAL

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

Drug: Intravenous administration of L-carnitine

control group

NO INTERVENTION

No intervention

Interventions

Intravenous administration of L-carnitine DRUG

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

Also known as: Chronic intravenous administration of L-carnitine

Carnitine group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Toujinkai Hospital: lead

Study Officials

• Masato Nishimura, MD

  Toujinkai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of cardiovascular division

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: December 23, 2014
• Study Start: August 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 25, 2014

Record last verified: 2014-12