Glucagon-like Peptide-1 and Coronary Microvascular Dysfunction in Women With Angina Pectoris and no Coronary Stenosis

What Was Tested

This registered phase 4 trial tested Liraglutide.

The aim of the present study is to evaluate the effect of treatment with Liraglutide on the coronary microvasculature and angina symptoms, in overweight patients with microvascular dysfunction and angina pectoris but no coronary artery stenosis.

It had 1 arm (groups): Liraglutide (experimental).

The registry classes the interventions as drug.

More on the Plan

Background: Patients with symptoms and signs of ischemia are referred to coronary angiography (CAG) or CT angiography (CT-CAG).

Abnormal coronary flow and metabolic response to stress have been reported, which is consistent with a possible microvascular ethology for the symptoms.

Both endothelium- and non-endothelium dependent impaired coronary reactivity may contribute.

The endothelium dependent component has been linked to risk factors and pro-inflammatory processes promoting atherosclerosis.

Who Took Part

Enrollment: 33 actual participants took part.

It was open to women only aged from 40 years up to 75 years.

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

Examples of who could join: Women aged 40-75 with angina-like symptoms assessed by the Seattle Angina Questionnaire (SAQ). Women aged 40-75 with angina-like symptoms assessed by the Seattle Angina Questionnaire (SAQ). Impaired CFR assessed by echo Doppler flow (defined ratio≤2,5).

The full record lists 5 inclusion and 25 exclusion criteria; among the exclusions: allergy to dipyridamole, theophyllamine or liraglutide; previous myocardial infarction or revascularization; no episodes of chest pain within 6 months before inclusion.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Liraglutide study did not mask who received what.

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

It started in 2015-11-19 with completion listed for 2017-04-18.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline in Coronary Flow Reserve (time frame: Assessed at baseline, week 4 and week 18). Change from baseline in Angina Symptoms (time frame: Assessed at baseline, week 4 and week 18).

It also tracked 4 secondary outcomes, for example Change in endothelial function, Change in cardiac function, Change in body weight and Change in body composition.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Liraglutide in 33 people.

Its size is small, so on its own it can only give an early look.

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.