Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients

What Was Tested

This registered phase 4 trial tested L-Carnitine.

This study is intended to be a multicenter, prospective, non-randomized, controlled real-world study.

Patients receiving L-carnitine injection were included in the experimental group and the control group according to whether they received L-carnitine injection.

Patients receiving L-carnitine injection were included in the experimental group, and those receiving L-carnitine injection were included in the control group.To observe the effects of L-carnitine on cardiac function in hemodialysis patients.

It had two arms (groups): Test group (experimental) and Control group (no intervention).

The patients in the test group were injected with levocarnitine on each dialysis day, and other conventional treatment drugs such as hemodialysis drugs were maintained in the original scheme and recorded in detail on the CRF form.

The patients in the control group were the same as those in the test group, except that they were not treated with L-carnitine.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1008 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Maintenance hemodialysis patients;. 18 years\<80 years;. Have clear consciousness and independent behavior ability;. Before dialysis, the total carnitine concentration was less than 40 umol/L, or the free carnitine concentration was less than 35 umol/L.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: acute cardiovascular and cerebrovascular diseases occurred within 1 month;; infectious diseases occurred within 1 month; treatment with glucocorticoid or immunosuppressant;; patients who have used l-carnitine within 2 weeks.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when L-Carnitine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-01-15 with completion listed for 2023-06-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline in Left ventricular ejection fraction (time frame: baseline and week 12).

It also tracked 8 secondary outcomes, for example Change from baseline in Brain natriuretic peptide level, Change from baseline in left ventricular short axis shortening rate, Change from baseline in stroke volume, Change from baseline in the ratio of peak E to peak A of mitral valve blood flow velocity in early and late diastolic periods, Change from baseline in serum albumin and Change from baseline in upper arm circumference.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of L-Carnitine in 1008 people.

With 1008 participants it is a large trial for this field.

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.