Clinical Study of Liraglutide in Improving Cardiac Function for Patients With Ischemic Cardiomyopathy

What Was Tested

This registered not phased trial tested Liraglutide.

It had two arms (groups): Liraglutide intervention group (active comparator) and Control group (no intervention).

Control group will accept ischemic cardiomyopathy conventional drugs and a placebo.

The registry classes the interventions as drug.

More on the Plan

Secondary end point of the study was 1) New York Heart Association functional class, 2) left ventricular ejection fraction, 3) 6-minute walk test, 4) KCCQ clinical total score, 5) changes in blood glucose levels during follow-up, blood lipid levels and body weight.

Who Took Part

The registry lists 400 planned participants were the target.

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.

The full record lists 1 inclusion and 10 exclusion criteria; among the exclusions: valvular heart disease; dilated cardiomyopathy; patients requiring emergency pci.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-09 with completion listed for 2018-02.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): main adverse cardiovascular events (time frame: Followed up for 6 months after enrolled in the study).

It also tracked 4 secondary outcomes, for example New York Heart Association functional class, left ventricular ejection fraction, 6-minute walk test and KCCQ (Kansas City cardiomyopathy questionnaire) clinical total score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 400 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.