Clinical trial NCT02322697: Effect of Carnitine on Uremic Cardiomyopathy
Official title: Effects of Chronic Intravenous Administration of L-carnitine on Myocardial Fatty Acid Metabolism in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Fatty Acid Metabolism
Keywords: Carnitine
hemodialysis
fatty acid
imaging
heart
Lead sponsor: Toujinkai Hospital
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: changes in BMIPP summed scores of the SPECT imaging
timeFrame: one year: September 2013-October 2014 (up to 2 years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Toujinkai Hospital
name: Masato Nishimura, MD
role: PRINCIPAL_INVESTIGATOR
References: