Cardiovascular Effects of Apelin In Healthy Volunteers

What Was Tested

This registered early phase 1 trial tested Apelin.

Apelin is an endogenous peptide with physiological actions in the cardiovascular system.

Apelin can modulate vasomotor tone and is a potent endogenous inotrope.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

5 Healthy volunteers.

5 Healthy volunteers.

5 Healthy volunteers.

The registry classes the interventions as drug.

More on the Plan

Study Protocols Groups of 5 subjects will be assigned to receive one of three protocols.

Protocol 1: Five healthy volunteers will be asked to attend the clinical research facility on a total of 4 occasions as per the protocol below.

Visits 1 and 2 will occur over two consecutive days.

Participants will attend at 07.30 and be given a light breakfast.

Who Took Part

14 actual participants took part.

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: Healthy males or females \>18 years old. Willing and able to complete an informed consent form.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: unable to give informed consent; pregnant or lactating at screening; use of any investigation product or device within 30 days prior to study.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

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 2014-11 with completion listed for 2015-05.

It ran at 2 sites in United Kingdom (2).

What Was Measured

Researchers chose this as the main measure: Change in cardiac output between different methods of apelin administration (time frame: 10 hours). Change in blood pressure between different methods of apelin administration (time frame: 10 hours).

It also tracked 1 secondary outcome, for example Change in apelin concentrations between the different methods of administration.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Apelin in 14 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.