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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.