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Effect of Carnitine on Uremic Cardiomyopathy
Plain-language guide to NCT02322697: not phased randomized trial of L-Carnitine, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02322697
- Phase
- not phased
- Status
- completed
- Start
- 2013-08
- Completion (planned or actual)
- 2014-10
- Participants
- 60 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Disorder of Fatty Acid Metabolism
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test L-Carnitine.
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.
Control group received the examination of BMIPP SPECT at the same time of the carnitine group.
It had two arms (groups): Carnitine group (experimental) and control group (no intervention).
No intervention.
The registry classes the interventions as drug.
More on the Plan
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.
Who Took Part
Enrollment: 60 actual participants took part.
It was open to people of any sex aged from 40 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Left ventricular hypertrophy evaluated by echocardiography).
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: moderate or worse valvular heart disease,.
How the Study Was Run
It was run as a randomized, single-group and open-label study.
Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Being open-label, the L-Carnitine study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2013-08 with completion listed for 2014-10.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: changes in BMIPP summed scores of the SPECT imaging (time frame: one year: September 2013-October 2014 (up to 2 years)).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of L-Carnitine in 60 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the L-Carnitine compound page, all human trials.
Our Notes on the Compound
L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.