Effects of GLP-1 on Chronic Heart Failure

What Was Tested

The trial (not phased) is built around Liraglutide.

The investigators planned to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.

It had two arms (groups): GLP-1 group (experimental) and Control group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Heart failure (HF) is a major cause of morbidity and mortality world wide.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and has direct effects on the cardiovascular system.

However, the effects of GLP-1 on chronic heart failure patients with type 2 diabetes remain unclear.

The aim of this study was to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.

Who Took Part

Enrollment: 68 planned participants were the target.

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: Chronic heart failure patients with type 2 diabetes (NYHA-class I, II or III) were eligible for the study.

The full record lists 1 inclusion and 15 exclusion criteria; among the exclusions: CHF (NYHA class IV); type 1 diabetes; hospitalisation due to incompensated heart disease within 30 days prior to randomisation.

How the Study Was Run

Design: randomized, parallel-group and double-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.

The Liraglutide group and the comparison group ran side by side rather than switching.

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: investigator and outcomes assessor.

It started in 2016-01 with completion listed for 2018-02.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: left ventricular ejection fraction measured by 3D echocardiography (time frame: 3 months).

It also tracked 3 secondary outcomes, for example plasma NT-proBNP levels, a change in 6-minute walk distance and differences in the incidences of treatment-emergent adverse events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 68 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.