Local Haemodynamic Effects of Apelin Agonists and Antagonists in Man in Vivo

What Was Tested

This registered not phased trial tested Apelin.

Apelins are substances which occur naturally in the body, and have an important role in heart disease.

The investigators have devised 2 sets of experiments to investigate how the apelins affect blood vessels.

It had three arms (groups): Apelin agonist infusion (experimental), Apelin receptor antagonist infusion (experimental) and Apelin agonist/antagonist co-infusion (experimental).

Aellig hand vein technique will be used to investigate the change in vein diameter in response to an apelin blocking agent.

Forearm blood flow study to measure blood flow by forearm venous occlusion plethysmography following intraarterial infusion of apelin receptor agonists and antagonist.

The registry classes the interventions as other and procedure.

Who Took Part

The registry lists 52 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Between 18 and 70 years. Non-regular smoking (\<5 cigarettes per week). If female, postmenopausal or on days 2-9 of menstrual cycle.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: hypertension (sustained bp \>160/100mmhg); ischaemic heart disease; renal, respiratory or neurological disease.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

The participants were allocated by chance, so the Apelin group and the comparison group should start out alike.

Each person switched between Apelin and the comparison at some point, usually with a gap in between.

Everyone knew when Apelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-01 with completion listed for 2013-08.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Forearm blood flow measured by forearm plethysmography in response to infused vasodilators (time frame: 2-3 hours). Change in hand vein diameter measured by Aellig hand vein technique, in response to study peptides (time frame: 2-3 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Apelin in 52 people.

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

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