Adrenal Vein Sampling International Study (AVIS Study)

NCT01234220 | Completed DMC

• 1 other identifier: GPR-AVIS
• Study Type: observational
• Target: 2,604
• Locations: 10 countries
• Sites: 20

Brief Summary

The AVIS Study is a retrospective multicenter international study that aims to answer a series of questions on the use and performance of adrenal venous catheterization (AVS) for the diagnosis of primary hyperaldosteronism subtype. A questionnaire will be circulated among the centres that are internationally recognized and have published in the field of AVS and have agreed to participate in the study. The first aim of the AVIS study is to collect summary data on how AVS is being performed throughout the world to answer the following questions:

• How many AVS studies haw been performed yearly from 2005 to 2010 at each center?
• How many adrenal vein ruptures occurred during the AVS at each center?Has the rate of adrenal vein rupture been steady or has it changed over the 5 years?
• How many centers use bilaterally simultaneous and how many use sequential AVS catheterization?
• How many radiologists perform AVS at each center?
• How many centers use a cosyntropin stimulation during AVS?
• What is the percentage of PA patients in whom AVS is performed?
• How many centres calculate the selectivity index? What is the minimum cutoff used?
• How many centers calculate the lateralization index? What is the minimum cutoff used?
• Are the AVS studies that are not bilaterally selective used for diagnosis?
• How many centers calculate the controlateral suppression index and what is the minimum cutoff used?
• What is the cost of AVS for the National Health System or Insurance and for patients? The second aim of the study is to calculate the rate of AVS studies that are selective and show lateralization of aldosterone excess at each center by applying predefined set of criteria for defining selectivity and lateralization. Data on the final diagnosis of the PA subtype will be gathered and used as reference to assess the performance of AVS using receiver operating characteristic curves analysis and the Youden index to determine the optimal cutoffs. A worksheet will need to be completed providing information on the following: Demography; Date of AVS;Baseline blood pressure (BP) values and serum K+;Dynamic test during the AVS if any; plasma aldosterone and cortisol concentration in the infra-adrenal inferior vena cava and in the right and left adrenal vein; diagnosis of PA subtype; treatment (adrenalectomy or pharmacological therapy); post-treatment BP and serum K+ values; concordance/discordance between imaging (CT or RM) and AVS.

Conditions

Hyperaldosteronism

Keywords

Aldosterone; Primary Aldosteronism; Aldosterone Producing Adenoma (APA); Idiopathic Adrenal Hyperplasia (IHA); Adrenal Venous Sampling

Outcome Measures

Primary Outcomes (1)

• Number of adrenal vein ruptures occurring during AVS

  January 1st 2005 - November 1st 2010

Secondary Outcomes (4)

• AVS cost for the patient and the health insurance system

  January 1st 2005 - November 1st 2010

• number of selective AVS at right or left side

  January 1st 2005 - November 1st 2010

• number of bilaterally selective AVS

  January 1st 2005 - November 1st 2010

• number of lateralized AVS and number of the patients undergoing adrenalectomy

  January 1st 2005 - November 1st 2010

Study Arms (1)

Adrenal Venous Sampling (AVS)

Patients with Primary Aldosteronism (PA) undergoing AVS to discriminate PA forms with unilateral from bilateral excess aldosterone production.

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 patients with Primary Aldosteronism who underwent AVS during the last 5 years in 15 worldwide centers.

You may qualify if:

• consent of the leading investigator to participate to the data collection

You may not qualify if:

• refusal of the leading investigator to participate to the AVIS Study

Sponsors & Collaborators

• University Hospital Padova: lead

Study Sites (20)

Hospital of The University of Pennsylvania, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Medical College of Wisconsin

Menomonee Falls, Wisconsin, 53051, United States

Location

Endocrine Hypertension Research Centre, University of Queensland School of Medicine, Greenslopes Hospital

Brisbane, 4120, Australia

Location

Foothills Medical Centre, University of Calgary

Calgary, Alberta, Canada

Location

Centre Hospitalier de l'Université de Montreal (CHUM)

Montreal, Quebec, Canada

Location

General Faculty Hospital, Prague

Prague, Czechia

Location

University of Paris, Hopital Européen Georges Pompidou

Paris, France

Location

Christian J Strasburger

Berlin, 10117, Germany

Location

Heinrich Heine Universität Düsseldorf

Düsseldorf, Germany

Location

Medizinische Klinik Innenstadt

Munich, Germany

Location

University Hospital Wuerzburg

Würzburg, 97080, Germany

Location

Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy

Padua, Italy

Location

Medicina 2, Dipartimento di Medicina Interna e Specialità Mediche, Azienda Ospedaliera Santa Maria Nuova

Reggio Emilia, 42123, Italy

Location

National Hospital Organizatio, Kyoto Medical Center

Kyoto, Japan

Location

Tohoku University Hospital

Sendai, Japan

Location

Institute of Clinical Endocrinology, Tokyo Women's Medical University

Tokyo, Japan

Location

Yokohama Rosai Hospital

Yokohama, Japan

Location

Radboud University Nijmegen Medical Center

Nijmegen, 6525GA, Netherlands

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (14)

• Funder J, Carey R, Fardella C, Gomez-Sanchez C, Mantero F, Stowasser M, Young W, Montori VM. Withdrawn: Case detection, diagnosis, and treatment of patients with primary aldosteronism: an Endocrine Society clinical practice guideline. Eur J Endocrinol. 2009 Sep 30. doi: 10.1530/EJE-09-0870. Online ahead of print.

  PMID: 19793760 BACKGROUND

• Stewart PM, Allolio B. Adrenal vein sampling for Primary Aldosteronism: time for a reality check. Clin Endocrinol (Oxf). 2010 Feb;72(2):146-8. doi: 10.1111/j.1365-2265.2009.03714.x. Epub 2009 Sep 21. No abstract available.

  PMID: 19769616 BACKGROUND

• Seccia TM, Miotto D, De Toni R, Pitter G, Mantero F, Pessina AC, Rossi GP. Adrenocorticotropic hormone stimulation during adrenal vein sampling for identifying surgically curable subtypes of primary aldosteronism: comparison of 3 different protocols. Hypertension. 2009 May;53(5):761-6. doi: 10.1161/HYPERTENSIONAHA.108.128553. Epub 2009 Apr 6.

  PMID: 19349554 BACKGROUND

• Rossi GP, Pitter G, Bernante P, Motta R, Feltrin G, Miotto D. Adrenal vein sampling for primary aldosteronism: the assessment of selectivity and lateralization of aldosterone excess baseline and after adrenocorticotropic hormone (ACTH) stimulation. J Hypertens. 2008 May;26(5):989-97. doi: 10.1097/HJH.0b013e3282f9e66a.

  PMID: 18398342 BACKGROUND

• Mulatero P, Bertello C, Sukor N, Gordon R, Rossato D, Daunt N, Leggett D, Mengozzi G, Veglio F, Stowasser M. Impact of different diagnostic criteria during adrenal vein sampling on reproducibility of subtype diagnosis in patients with primary aldosteronism. Hypertension. 2010 Mar;55(3):667-73. doi: 10.1161/HYPERTENSIONAHA.109.146613. Epub 2010 Feb 1.

  PMID: 20124107 BACKGROUND

• Auchus RJ, Wians FH Jr, Anderson ME, Dolmatch BL, Trimmer CK, Josephs SC, Chan D, Toomay S, Nwariaku FE. What we still do not know about adrenal vein sampling for primary aldosteronism. Horm Metab Res. 2010 Jun;42(6):411-5. doi: 10.1055/s-0030-1252060. Epub 2010 Apr 21.

  PMID: 20411476 BACKGROUND

• Nishikawa T, Saito J, Omura M. Adrenal venous sampling is absolutely requisite for definitively diagnosing primary aldosteronism as well as for detecting laterality of the adrenal lesion. Hypertens Res. 2007 Nov;30(11):1009-10. doi: 10.1291/hypres.30.1009. No abstract available.

  PMID: 18250546 BACKGROUND

• Pintus G, Seccia TM, Amar L, Azizi M, Riester A, Reincke M, Widimsky J, Naruse M, Kocjan T, Negro A, Kline G, Tanabe A, Satoh F, Rump LC, Vonend O, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Lee BC, Chang CC, Wu VC, Kratka Z, Battistel M, Bagordo D, Caroccia B, Ceolotto G, Rossitto G, Rossi GP. Subtype Identification of Surgically Curable Primary Aldosteronism During Treatment With Mineralocorticoid Receptor Blockade. Hypertension. 2024 Jun;81(6):1391-1399. doi: 10.1161/HYPERTENSIONAHA.124.22721. Epub 2024 Mar 25.

  PMID: 38525605 DERIVED

• Rossi GP, Bagordo D, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J, Naruse M, Deinum J, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Rump LC, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Lee BC, Chang CC, Wu VC, Kratka Z, Battistel M, Rossitto G, Seccia TM. Unilaterally Selective Adrenal Vein Sampling for Identification of Surgically Curable Primary Aldosteronism. Hypertension. 2023 Oct;80(10):2003-2013. doi: 10.1161/HYPERTENSIONAHA.123.21247. Epub 2023 Jun 15.

  PMID: 37317838 DERIVED

• Rossi GP, Crimi F, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J, Naruse M, Deinum J, Kool LS, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Rump LC, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Wu VC, Kratka Z, Barbiero G, Battistel M, Seccia TM. Feasibility of Imaging-Guided Adrenalectomy in Young Patients With Primary Aldosteronism. Hypertension. 2022 Jan;79(1):187-195. doi: 10.1161/HYPERTENSIONAHA.121.18284. Epub 2021 Nov 17.

  PMID: 34878892 DERIVED

• Rossi GP, Crimi F, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J, Naruse M, Deinum J, Schultze Kool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Christian Rump L, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Cent Wu V, Kratka Z, Barbiero G, Seccia TM, Battistel M. Identification of Surgically Curable Primary Aldosteronism by Imaging in a Large, Multiethnic International Study. J Clin Endocrinol Metab. 2021 Oct 21;106(11):e4340-e4349. doi: 10.1210/clinem/dgab482.

  PMID: 34212188 DERIVED

• Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J, Naruse M, Deinum J, Schultzekool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Rump LC, Vonend O, Willenberg HS, Fuller P, Yang J, Nian Chee NY, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Chang CC, Wu VC, Somloova Z, Maiolino G, Barbiero G, Battistel M, Lenzini L, Quaia E, Pessina AC, Rossi GP. Subtyping of Primary Aldosteronism in the AVIS-2 Study: Assessment of Selectivity and Lateralization. J Clin Endocrinol Metab. 2020 Jun 1;105(6):dgz017. doi: 10.1210/clinem/dgz017.

  PMID: 31536622 DERIVED

• Rossi GP, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J Jr, Naruse M, Deinum J, Schultze Kool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Christian Rump L, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Dun Wu K, Wu VC, Kratka Z, Barbiero G, Battistel M, Chang CC, Vanderriele PE, Pessina AC. Clinical Outcomes of 1625 Patients With Primary Aldosteronism Subtyped With Adrenal Vein Sampling. Hypertension. 2019 Oct;74(4):800-808. doi: 10.1161/HYPERTENSIONAHA.119.13463. Epub 2019 Sep 3.

  PMID: 31476901 DERIVED

• Rossi GP, Barisa M, Allolio B, Auchus RJ, Amar L, Cohen D, Degenhart C, Deinum J, Fischer E, Gordon R, Kickuth R, Kline G, Lacroix A, Magill S, Miotto D, Naruse M, Nishikawa T, Omura M, Pimenta E, Plouin PF, Quinkler M, Reincke M, Rossi E, Rump LC, Satoh F, Schultze Kool L, Seccia TM, Stowasser M, Tanabe A, Trerotola S, Vonend O, Widimsky J Jr, Wu KD, Wu VC, Pessina AC. The Adrenal Vein Sampling International Study (AVIS) for identifying the major subtypes of primary aldosteronism. J Clin Endocrinol Metab. 2012 May;97(5):1606-14. doi: 10.1210/jc.2011-2830. Epub 2012 Mar 7.

  PMID: 22399502 DERIVED

MeSH Terms

Conditions

Hyperaldosteronism; Adrenocortical Adenoma

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Cortex Diseases

Study Officials

• GianPaolo Rossi, MD, FACC

  Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FAHA, FACC

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 4, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

IT (2); AU (1); JP (4); NL (1); CA (2); CZ (1); FR (1); DE (4); TW (1); US (3)