Interaction of Apelin and Angiotensin in the Systemic Circulation

What Was Tested

The trial (not phased) is built around 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): Angiotensin II (active comparator) and Saline infusion (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 12 planned participants were the target.

It was open to men only 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 10 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.

Random assignment meant chance, not the researchers, decided who got Angiotensin II and who got the comparison, which limits bias.

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

As a double-blind Angiotensin II study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2010-01 with completion listed for 2010-04.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Cardiac output (time frame: 90 mins).

It also tracked 1 secondary outcome, for example Systemic haemodynamics.

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.