Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers (Protocol 2)

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): Saline Placebo (placebo comparator) and Response to Urocortin infusion in presence of Astressin 2B (active comparator).

The registry classes the interventions as drug.

Who Took Part

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.

The participants were allocated by chance, so the Urocortin group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Urocortin and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant and investigator.

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

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Forearm blood flow (time frame: 2.30 hours).

It also tracked 1 secondary outcome, for example Net t-PA release.

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.