Clinical trial · Observational
Adrenal Vein Sampling International Study (AVIS Study)
Multicenter Study on Use and Interpretation of Adrenal Vein Sampling
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperaldosteronism | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Adrenal Venous Sampling (AVS)
- description
- Patients with Primary Aldosteronism (PA) undergoing AVS to discriminate PA forms with unilateral from bilateral excess aldosterone production.
Primary outcomes (1)
- measure
- Number of adrenal vein ruptures occurring during AVS
- timeFrame
- January 1st 2005 - November 1st 2010
Secondary outcomes (4)
- measure
- AVS cost for the patient and the health insurance system
- timeFrame
- January 1st 2005 - November 1st 2010
- description
- The amount in euros that the patient and the health insurance system has to pay for the AVS study will be estimated in each center.
- measure
- number of selective AVS at right or left side
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * consent of the leading investigator to participate to the data collection Exclusion Criteria: * refusal of the leading investigator to participate to the AVIS Study
References
Publications (14)
- BACKGROUNDFunder 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
- BACKGROUNDStewart 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
- BACKGROUNDSeccia 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
- BACKGROUNDRossi 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
- BACKGROUNDMulatero 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
- BACKGROUNDAuchus 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.