The Effect of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes Mellitus

What Was Tested

The trial (not phased) is built around Liraglutide.

Type 2 diabetes (T2D) is a major risk factor of chronic heart failure (CHF).

Glycemic control in patients with the combination of T2D and CHF is complicated and the currently available treatments have proven to be inadequate in clinical trials.

It had two arms (groups): Liraglutid (active comparator) and Placebo (placebo comparator).

Liraglutid.

Placebo.

The registry classes the interventions as drug.

More on the Plan

Therefore, new treatment modalities of hyperglycaemia in CHF are warranted.

Glucagon-like peptide 1 (GLP-1) is a naturally existing hormone, which is secreted from the incretine system.

Liraglutide (Victoza®) is a GLP-1-analogue developed for the treatment of T2D.

However, the impact of Liraglutide on cardiac function is currently under investigation.

Who Took Part

240 actual participants took part.

It was open to people of any sex aged from 30 years up to 85 years.

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

Examples of who could join: Able to understand the written patient information and to give informed consent. CHF, NYHA-class I, II or III at visit 0. Age 30 to 85 (both inclusive). T2D (WHO criteria), diagnosed at least 3 months prior to visit 0.

The full record lists 8 inclusion and 22 exclusion criteria; among the exclusions: myocardial infarction (mi), unstable angina or coronary revascularization within the last three months prior to visit 1; hospitalisation due to incompensated heart disease within 30 days prior to randomisation (visit 1); CHF (NYHA class IV).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2011-11 with completion listed for 2015-09.

It ran at 4 sites in Denmark (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Left ventricular function from visit 1 to week 24, measured by Ecco (time frame: 24 weeks).

It also tracked 1 secondary outcome, for example left ventricular diastolic function.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 240 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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