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

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ClinicalTrials.gov Identifier: NCT04378387
Recruitment Status : Completed
First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Mauro Maccario, University of Turin, Italy

Brief Summary:
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.

Condition or disease
Primary Aldosteronism Primary Aldosteronism Due to Aldosterone Producing Adenoma Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Usefulness of the Ipsilateral and Contralateral Index for the Interpretation of Adrenal Vein Sampling (AVS) in the Subtype Diagnosis of Primary Aldosteronism
Actual Study Start Date : January 1, 2005
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : April 30, 2020





Primary Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients followed by our center with age over 18 years old and a diagnosis of primary aldosteronism, who underwent a successful (i.e. with successful catheterization of both adrenal veins) unstimulated adrenal vein sampling between January 2005 and April 2020.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378387


Locations
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Italy
Division of Endocrinology, Diabetology and Metabolism; University of Turin
Torino, Piemonte, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Investigators
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Principal Investigator: Mauro Maccario, MD Endocrinology, Diabetology and Metabolism; University of Turin
Study Chair: Ezio Ghigo, MD Endocrinology, Diabetology and Metabolism; University of Turin
Publications:

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Responsible Party: Mauro Maccario, Medical Doctor, Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT04378387    
Other Study ID Numbers: ICI-AVS
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mauro Maccario, University of Turin, Italy:
Primary Aldosteronism
Primary Aldosteronism Due to Aldosterone Producing Adenoma
Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Adrenal Vein Sampling
Renin-Angiotensin-Aldosterone System
Blood Pressure
Lateralization Index
Ipsilateral Index
Contralateral Index
Additional relevant MeSH terms:
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Adenoma
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Hyperaldosteronism
Hyperplasia
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Gonadal Disorders