Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers - Protocol 4

What Was Tested

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

Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem with a poor prognosis and the search for novel treatments remains an important area of research.

There has been particular interest in the role of Urocortins 2 \& 3 (subtypes of Urocortins) in heart failure.

It had two arms (groups): Urocortin 2 (other) and Urocortin 3 (other).

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 65 years.

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

Examples of who could join: Healthy male volunteers between 18 - 65 years (inclusive).

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: lack of informed consent- age \<18 years \> 65 years; current involvement in a clinical trial; history of anaemia.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Urocortin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2011-02 with completion listed for 2011-06.

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: Forearm blood flow (time frame: 3.5 hours).

It also tracked 1 secondary outcome, for example Plasma Urocortin 2 and 3 levels.

What This Means in Plain Language

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