Corticotropin Stimulation in Adrenal Venous Sampling for Patients With Primary Aldosteronism(ADOPA)

What Was Tested

The trial (not phased) is built around ACTH (Corticotropin).

To compare the effect of different procedures of AVS(with or without ACTH stimulation) on the long-term outcomes of patients with PA.

It had two arms (groups): AVS with ACTH stimulation (experimental) and AVS without ACTH stimulation (no intervention).

Patients divided into AVS with ACTH stimulation group need to undergo stimulation with a continuous cosyntropin infusion.

Patients divided into AVS without ACTH stimulation group take the same procedure of AVS with a continuous saline infusion.

The registry classes the interventions as drug.

More on the Plan

This is a prospective and randomized study involving patients with primary aldosteronism(PA) who completed AVS.

All paticipants will be randomized into ACTH-stimulated group(Intervention group) and ACTH-unstimulated group(Control group) Cannulation was considered successful when the selectivity index (SI), namely plasma cortisol concentration (PCC) in adrenal vein/PCC in IVC≥3 with ACTH stimulation or SI≥2 without ACTH stimulation.

The ratio of PAC: PCC on the side with the higher ratio over the contralateral PAC: PCC ratio is defined as the lateralization index (LI).

Lateralization of aldosterone excess was defined as LI≥4 irrespective of ACTH use.

Who Took Part

Enrollment: 228 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Inclusion criteria: Patients who meet the following criterion can be included in this study. Aged between 18-70, male or female, with legal capacity.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: refusal by the patient to undergo avs or adrenalectomy;; allergic to acth or contrast media;; pregnant or lactating women;.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this ACTH (Corticotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.

In this single-blind ACTH (Corticotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2020-07-08 with completion listed for 2023-02-20.

It ran at 1 site in China.

Its stated primary purpose is diagnostic.

What Was Measured

It also tracked 4 secondary outcomes, for example Rate of bilaterally successful AVS and Adverse events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of ACTH (Corticotropin) in 228 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, all human trials.