Investigating the Inotropic Potential of Apelin

What Was Tested

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

The apelin-APJ system is a recently discover hormone system that has several important actions in the cardiovascular system.

Apelin causes the heart pump with more force and also causes blood vessels to relax.

It had two arms (groups): Apelin infusion (experimental) and Placebo (placebo comparator).

6 hour infusion of apelin peptide into circulation.

Infusion of saline into systemic circulation.

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: New York Heart Failure class II-IV.

The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: females of child bearing age not on adequate contraception; lack of informed consent; age \<18yrs.

How the Study Was Run

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2010-08 with completion listed for 2012-07.

It ran at 3 sites in United Kingdom (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: cardiac output (time frame: 6 hours).

It also tracked 2 secondary outcomes, for example Urine volume and Pulmonary artery pressure.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Apelin in 24 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.