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

NCT04378387 | Completed DMC

• 1 other identifier: ICI-AVS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism; Primary Aldosteronism Due to Aldosterone Producing Adenoma; Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Division of Endocrinology, Diabetology and Metabolism; University of Turin

Turin, Piedmont, 10126, Italy

Location

Related Publications (8)

• 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.

  PMID: 26934393 BACKGROUND

• 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.

  PMID: 28385310 BACKGROUND

• 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. doi: 10.1016/j.jacc.2006.07.059. Epub 2006 Nov 13.

  PMID: 17161262 BACKGROUND

• 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.

  PMID: 26435431 BACKGROUND

• 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.

  PMID: 29176594 BACKGROUND

• 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. No abstract available.

  PMID: 26706611 BACKGROUND

• 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.

  PMID: 29174432 BACKGROUND

• 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.

  PMID: 29124355 BACKGROUND

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Mauro Maccario, MD

  Endocrinology, Diabetology and Metabolism; University of Turin

  PRINCIPAL INVESTIGATOR

• Ezio Ghigo, MD

  Endocrinology, Diabetology and Metabolism; University of Turin

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Professor

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: January 1, 2005
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)