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

Primary Aldosteronism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378387
• Other study ID #: ICI-AVS
• Status: Completed
• Start date: January 1, 2005
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenoma
• Adrenal Hyperplasia, Congenital
• Adrenogenital Syndrome
• Hyperaldosteronism
• Hyperplasia
• Primary Aldosteronism
• Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
• Primary Aldosteronism Due to Aldosterone Producing Adenoma

Locations

Country	Name	City	State
Italy	Division of Endocrinology, Diabetology and Metabolism; University of Turin	Torino	Piemonte

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Fujii Y, Umakoshi H, Wada N, Ichijo T, Kamemura K, Matsuda Y, Kai T, Fukuoka T, Sakamoto R, Ogo A, Suzuki T, Nanba K, Tsuiki M, Naruse M; WAVES-J Study Group. Subtype prediction of primary aldosteronism by combining aldosterone concentrations in the left adrenal vein and inferior vena cava: a multicenter collaborative study on adrenal venous sampling. J Hum Hypertens. 2017 Dec;32(1):12-19. doi: 10.1038/s41371-017-0015-0. Epub 2017 Nov 24. — View Citation

Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2. — View Citation

Lee BC, Chang CC; TAIPAI Study Group. Regarding "Diagnostic utility of data from adrenal venous sampling for primary aldosteronism despite failed cannulation of the right adrenal vein". Surgery. 2016 May;159(5):1478-9. doi: 10.1016/j.surg.2015.10.033. Epub 2015 Dec 17. — View Citation

Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052. — View Citation

Pasternak JD, Epelboym I, Seiser N, Wingo M, Herman M, Cowan V, Gosnell JE, Shen WT, Kerlan RK Jr, Lee JA, Duh QY, Suh I. Diagnostic utility of data from adrenal venous sampling for primary aldosteronism despite failed cannulation of the right adrenal vein. Surgery. 2016 Jan;159(1):267-73. doi: 10.1016/j.surg.2015.06.048. Epub 2015 Oct 2. — View Citation

Rossi GP, Bernini G, Caliumi C, Desideri G, Fabris B, Ferri C, Ganzaroli C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Mattarello MJ, Moretti A, Palumbo G, Parenti G, Porteri E, Semplicini A, Rizzoni D, Rossi E, Boscaro M, Pessina AC, Mantero F; PAPY Study Investigators. A prospective study of the prevalence of primary aldosteronism in 1,125 hypertensive patients. J Am Coll Cardiol. 2006 Dec 5;48(11):2293-300. Epub 2006 Nov 13. — View Citation

Strajina V, Al-Hilli Z, Andrews JC, Bancos I, Thompson GB, Farley DR, Lyden ML, Dy BM, Young WF, McKenzie TJ. Primary aldosteronism: making sense of partial data sets from failed adrenal venous sampling-suppression of adrenal aldosterone production can be used in clinical decision making. Surgery. 2018 Apr;163(4):801-806. doi: 10.1016/j.surg.2017.10.012. Epub 2017 Nov 22. — View Citation

Wang TS, Kline G, Yen TW, Yin Z, Liu Y, Rilling W, So B, Findling JW, Evans DB, Pasieka JL. A Multi-institutional Comparison of Adrenal Venous Sampling in Patients with Primary Aldosteronism: Caution Advised if Successful Bilateral Adrenal Vein Sampling is Not Achieved. World J Surg. 2018 Feb;42(2):466-472. doi: 10.1007/s00268-017-4327-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monolateral index for each adrenal gland in each patient	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).	At AVS procedure
Primary	Aldosterone/cortisol index for each adrenal gland in each patient	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).	At AVS procedure