Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Heart Failure

What Was Tested

This registered phase 1, phase 2 trial tested Ghrelin.

It had two arms (groups): Ghrelin infusion (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as biological.

Who Took Part

31 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Current or past signs of clinical HF according to the Framingham criteria. NT-proBNP \> 300 ng/L.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: inability to or unwillingness to provide informed consent,; participation in research study that involves research drug administration or contraindication to any of the clinically indicated procedures.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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

The Ghrelin group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-02-17 with completion listed for 2014-05-22.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in cardiac output between treament groups (time frame: Procedure (At the end of ghrelin administration)).

It also tracked 4 secondary outcomes, for example Change in endothelial function between treament groups, Change in cardiac function between treament groups, GH biomarker and ghrelin biomarker.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Ghrelin in 31 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 Ghrelin compound page, all human trials.