← Human Trials & Peer-Reviewed Studies

Interaction of Apelin and Angiotensin in the Human Forearm Circulation

Plain-language guide to NCT00901888: not phased randomized trial of Apelin, 12 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00901888
Phase
not phased
Status
completed
Start
2009-04
Completion (planned or actual)
2010-05
Participants
12 (estimated)
Design
randomized, double-blind, basic_science
Conditions studied
Heart Disease; Vasodilation
Results posted
not yet

What This Study Did, in Plain Language

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): Angiotensin II infusion (experimental) and Noradrenaline (active comparator).

The registry classes the interventions as drug.

Who Took Part

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 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

The set-up was randomized, crossover and double-blind.

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.

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

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

Those kept unaware of assignments: participant and investigator.

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

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change in apelin mediated forearm blood flow (time frame: 12 months).

It also tracked 1 secondary outcome, for example Change in local and systemic plasma apelin concentration in response angiotensin II infusion.

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.

Our Notes on the Compound

Apelin: A peptide hormone family that acts on the heart and blood vessels; studied as an infusion in heart and lung research.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.