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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01234220




Registration number
NCT01234220
Ethics application status
Date submitted
2/11/2010
Date registered
4/11/2010
Date last updated
15/01/2013

Titles & IDs
Public title
Adrenal Vein Sampling International Study (AVIS Study)
Scientific title
Multicenter Study on Use and Interpretation of Adrenal Vein Sampling
Secondary ID [1] 0 0
GPR-AVIS
Universal Trial Number (UTN)
Trial acronym
AVIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperaldosteronism 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Adrenal Venous Sampling (AVS) - Patients with Primary Aldosteronism (PA) undergoing AVS to discriminate PA forms with unilateral from bilateral excess aldosterone production.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of adrenal vein ruptures occurring during AVS
Timepoint [1] 0 0
January 1st 2005 - November 1st 2010
Secondary outcome [1] 0 0
AVS cost for the patient and the health insurance system
Timepoint [1] 0 0
January 1st 2005 - November 1st 2010
Secondary outcome [2] 0 0
number of selective AVS at right or left side
Timepoint [2] 0 0
January 1st 2005 - November 1st 2010
Secondary outcome [3] 0 0
number of bilaterally selective AVS
Timepoint [3] 0 0
January 1st 2005 - November 1st 2010
Secondary outcome [4] 0 0
number of lateralized AVS and number of the patients undergoing adrenalectomy
Timepoint [4] 0 0
January 1st 2005 - November 1st 2010

Eligibility
Key inclusion criteria
- consent of the leading investigator to participate to the data collection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- refusal of the leading investigator to participate to the AVIS Study

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
2604
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Endocrine Hypertension Research Centre, University of Queensland School of Medicine, Greenslopes Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4120 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
United States of America
State/province [3] 0 0
Wisconsin
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Prague
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
Germany
State/province [8] 0 0
Berlin
Country [9] 0 0
Germany
State/province [9] 0 0
Düsseldorf
Country [10] 0 0
Germany
State/province [10] 0 0
Munich
Country [11] 0 0
Germany
State/province [11] 0 0
Wuerzburg
Country [12] 0 0
Italy
State/province [12] 0 0
Padua
Country [13] 0 0
Italy
State/province [13] 0 0
Reggio Emilia
Country [14] 0 0
Japan
State/province [14] 0 0
Kyoto
Country [15] 0 0
Japan
State/province [15] 0 0
Sendai
Country [16] 0 0
Japan
State/province [16] 0 0
Tokyo
Country [17] 0 0
Japan
State/province [17] 0 0
Yokohama City
Country [18] 0 0
Netherlands
State/province [18] 0 0
Nijmegen
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital Padova
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01234220
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
GianPaolo Rossi, MD, FACC
Address 0 0
Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01234220