Ipsilateral and Contralateral Index for the Interpretation of Adrenal Vein Sampling (AVS) in Primary Aldosteronism

Adrenal vein sampling (AVS) is currently considered the gold standard for subtype diagnosis of primary aldosteronism (PA). However, the percentage of unsuitable procedures due to the unsuccessful cannulation of one of the two adrenal veins is still considerable, and there is no general consensus on the criteria that should be used for the interpretation of the results of an AVS study in these specific cases.

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral) Primary Aldosteronism Due to Aldosterone Producing Adenoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Endocrinology, Diabetology and Metabolism; University of Turin

Turin, Piedmont, 10126, Italy

About this study

The differentiation between subtypes of primary aldosteronism (PA) is fundamental to refer each patient to the most appropriate therapeutic approach (surgical in case of unilateral disease and medical in case of bilateral disease). Adrenal vein sampling (AVS) is currently considered the gold standard for such differentiation between subtypes.

However, despite significant progress in optimizing the AVS procedure, the percentage of unsuitable procedures due to the unsuccessful cannulation of one of the two adrenal veins is still considerable, especially in less experienced centers.

It would therefore be important to identify criteria for the interpretation of the results of a suboptimal AVS study (i.e. with sampling of only one of the two adrenal veins). This problem has recently been addressed by some groups; however, there is still no general consensus on these criteria and all existing studies must be considered exploratory in this field.

In this study, therefore, all patients with PA followed by our center and who underwent a successful (i.e. with correct cannulation and sampling from both adrenal veins) unstimulated (i.e. without cosyntropin stimulation) AVS procedure will be retrospectively evaluated.

If a reliable unilateral index could be identified for subtype diagnosis, this tool could be used for the interpretation of suboptimal AVS data, thus preventing a certain percentage of patients from the necessity to repeat the procedure and allowing to refer each one, also on the basis of an incomplete dataset, to the most appropriate therapeutic approach.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Confirmed Diagnosis of Primary Aldosteronism
Execution of Adrenal Vein Sampling (AVS) for Subtype Diagnosis

Exclusion criteria

Execution of AVS in stimulated condition (i.e. with cosyntropin stimulation)
Inability to achieve successful catheterization of one or both adrenal veins during AVS (as established by adrenal/peripheral vein cortisol ratio)

Treatment and study plan

Primary outcomes

Monolateral index for each adrenal gland in each patient

Time frame: At AVS procedure

For each adrenal gland, monolateral index will be computed by dividing the ratio of aldosterone/cortisol in its adrenal vein by the ratio of aldosterone/cortisol in a peripheral vein. By definition, this will be a unitless index. The index will be compared between three main groups of interest (i.e. adrenal glands with a final diagnosis of ipsilateral Conn adenoma, adrenal glands with a final diagnosis of contralateral Conn adenoma, adrenal glands with a final diagnosis of bilateral adrenal hyperplasia).
Aldosterone/cortisol index for each adrenal gland in each patient

Time frame: At AVS procedure

For each adrenal gland, aldosterone/cortisol index represents the ratio of aldosterone/cortisol in its adrenal vein. Aldosterone will be measured in pg/ml, cortisol will be measured in mcg/l. The index will be compared between three main groups of interest (i.e. adrenal glands with a final diagnosis of ipsilateral Conn adenoma, adrenal glands with a final diagnosis of contralateral Conn adenoma, adrenal glands with a final diagnosis of bilateral adrenal hyperplasia).

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Usefulness of the Ipsilateral and Contralateral Index for the Interpretation of Adrenal Vein Sampling (AVS) in the Subtype Diagnosis of Primary Aldosteronism

Important dates

Study start: 2005
Primary completion: 2020
Study completion: 2020
First posted: May 7, 2020
Registry last updated: May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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