The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure

What Was Tested

The trial (phase 2, phase 3) is built around L-Carnitine.

A prospective, multicenter, randomized, double-blind, parallel, placebo-controlled clinical study was performed.

Treatment period: 7 days, follow-up: 1 month.

It had two arms (groups): Levocarnitine (placebo comparator) and L-carnitine (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 268 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: The subject aged ≥ 18 years, men or women. The subject needs hospitalization because of heart failure and will stay in hospital for more than 7 days. The subject's UCG shows that LVEF ≤ 45％ (left heart failure). The subject has signed the ICF.

The full record lists 7 inclusion and 20 exclusion criteria; among the exclusions: subjects with medical history of heart failure caused by valvular heart disease, mechanical obstruction, pericardial disease and myocardial amyloidosis; subjects with heart function class iv that have unstable hemodynamics and need final stage cardiac transplantation and intravenous vasoactive drugs; subjects will leave the hospital in 7 days.

How the Study Was Run

Design: randomized, single-group and double-blind.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and investigator.

It started in 2011-01 with completion listed for 2012-03.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: NYHA cardiac functional grading (time frame: 7 days treatment).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of L-Carnitine in 268 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.