Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)

What Was Tested

This registered not phased trial tested Cosyntropin.

This study will compare normal volunteers to those with Postural Tachycardia Syndrome (POTS).

It had two arms (groups): Low Salt Diet POTS (experimental) and Low Sodium Diet Controls (experimental).

The registry classes the interventions as drug.

More on the Plan

Patients with postural tachycardia syndrome had a subnormal increment in aldosterone with upright posture, which might reflect a blunted adrenal response to stimulation upon assuming upright posture.

In this AIM, the researchers propose to assess the adrenal response to aldosterone stimulation with intravenous adrenocorticotropin hormone.

For this protocol, subjects enrolled in the parent study will be approached about this sub-study.

Subjects will be assured that they are not required to participate in this study even if they choose to participate in the parent study.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Selected to match profiles of POTS patients (gender, age). Not using vasoactive medication. Age between 18-50 years. Male and female subjects are eligible. Able and willing to provide informed consent.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: overt cause for postural tachycardia (such as acute dehydration); inability to give, or withdrawal of, informed consent.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Being open-label, the Cosyntropin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-01 with completion listed for 2020-12-31.

It ran at 1 site in United States.

Its stated primary purpose is other.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cosyntropin in 13 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cosyntropin compound page, all human trials.