Investigating Systemic and Local Vascular Responses to Apelin in the Context of Renin-angiotensin Upregulation

What Was Tested

This registered not phased trial tested Apelin.

The apelin-APJ system is a relatively new discovery.

It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease.

It had two arms (groups): Sodium depletion (experimental) and Normal diet (placebo comparator).

Subjects will be randomised to a normal diet, with no restriction on sodium intake during the three days prior to the study.

The registry classes the interventions as drug.

Who Took Part

The registry lists 12 planned participants were the target.

It was open to people of any sex aged from 18 months up to 85 years.

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

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: lack of informed consent; age \< 18 years,; current involvement in other research studies,.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

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

In the crossover set-up each of the participants took both Apelin and the comparison in turn, acting as their own control.

Only one side, usually the participants, was kept unaware of whether Apelin was given.

Those kept unaware of assignments: investigator.

It started in 2010-04 with completion listed for 2010-05.

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: Change in cardiac output (time frame: 12 months). Change in apelin mediated vasodilatation (time frame: 12 months).

It also tracked 2 secondary outcomes, for example Change in systemic haemodynamics and Change in relevant neurohumoral hormones.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Apelin in 12 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 Apelin compound page, all human trials.