Interaction of Apelin and Angiotensin in the Human Forearm Circulation

What Was Tested

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

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): Infusion of apelin (experimental) and Sodium nitroprusside infusion (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 12 planned participants were the target.

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

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

Examples of who could join: \> 18 years old.

The full record lists 2 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

Design: randomized, crossover and double-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Angiotensin II.

Those kept unaware of assignments: participant and investigator.

It started in 2009-05 with completion listed for 2010-04.

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 angiotensin II mediated vasoconstriction (time frame: 12 months).

It also tracked 1 secondary outcome, for example Changes in relevant neurohumoral hormones in response to apelin infusion.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Angiotensin II 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 Angiotensin II compound page, all human trials.