GLP-1 and Hyperoxia for Organ Protection in Heart Surgery

What Was Tested

In this not phased trial, researchers set out to test Exenatide.

Patients undergoing open heart surgery are at risk of suffering damage to the heart, brain and kidneys.

This study is designed as a 2-by-2 randomized clinical trial with the purpose of investigating the organ protective effects of the glucagon-like-peptide-1 (GLP-1) agonist Exenatide versus placebo and restrictive versus liberal oxygenation during weaning from cardio-pulmonary bypass.

It had four arms (groups): GLP-1 (experimental), Placebo (placebo comparator), Restrictive Oxygenation (experimental) and Liberal Oxygenation (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patients with coronary artery disease (CAD) have associated atherosclerotic renal and cerebral disease making these organs especially vulnerable to ischemia during open heart surgery.

The primary indication is CAD with or without associated valvular disease.

Surgical treatment of patients with CAD is performed as coronary artery bypass grafting (CABG) or off- pump coronary artery bypass grafting (OPCAB).

CABG requires the use of extracorporeal circulation, while this is not the case for OPCAB.

Who Took Part

1400 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: Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained. ≥ 18 years of age at the time of signing informed consent.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: active treatment with glp-1 agonists; obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism or history of or active acute pancreatitis; acute (i.e. off hours, within hours surgery), sub-acute surgery (i.e. the following days) are eligible.

How the Study Was Run

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

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

As a double-blind Exenatide 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 2016-02 with completion listed for 2024-09.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time in days to the first occurring of the following co-primary end-points throughout the follow-up period (time frame: Minimum 12 months).

It also tracked 2 secondary outcomes, for example Time in days to the occurrence of individual end-points throughout the follow-up period and Incidence of serious adverse events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 1400 people.

With 1400 participants it is a large trial for this field.

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

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